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Study Group 1 DEFINITION OF MEDICAL DEVICE. Maria Judite Neves MDEG, MSOG INFARMED Lisbon, Portugal . MEDICAL DEVICE Why a harmonized definition ?. Harmonized definition offers significant benefits to the manufacturer, user, patient or consumer and to Regulatory Authorities;

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  • Study Group 1

  • DEFINITION OF MEDICAL DEVICE

Maria Judite Neves

MDEG, MSOG

INFARMED

Lisbon, Portugal


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MEDICAL DEVICEWhy a harmonized definition ?

  • Harmonized definition offers significant benefits to the manufacturer, user, patient or consumer and to Regulatory Authorities;

  • Supports global convergence of regulatory systems;

  • Decreases the cost of regulatory compliance;

  • Allows patients earlier access to new technologies and treatments

GHTF/SG1/N29R16:2005


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MEDICAL DEVICE Definition

which doesn’t achieve its primary intended action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted in its intended function by such means

  • Instrument

  • Apparatus

  • Implant

  • Machine

  • Appliance

  • Software

  • Material

  • Other similar or related article

  • Diagnosis

  • Prevention

  • Monitoring

  • Treatment

  • Alleviation

  • Compensation

  • Investigation, replacement, modification, or support of the anatomy or of a physiological process

  • Supporting or sustaining life

  • Control of conception

  • Disinfection of medical devices

disease

/

injury

GHTF/SG1/N29R16:2005


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Low Risk


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Low Risk


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Low Risk and Reusable


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Low Risk and Reusable


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Low Risk and Sterile


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Low Risk with Measure function


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Medium Risk


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Medium Risk


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Medium Risk

High Risk


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High Risk


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High Risk


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Custom made medical devices


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Medical Device Technologies

  • Cardiac Arrhythmias

  • Heart Failure

  • Sudden Cardiac Death

  • Coronary Artery Disease

  • Heart Valve Disease

  • G/I Reflux

  • Incontinence

  • Peripheral Vascular Disease

  • Neurological Conditions

  • Ear, Nose & Throat Disorders

  • Spinal Disorders

  • Spasticity

  • Chronic Pain

  • Diabetes Management


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New Medical Technologies

Minimally invasive surgery

High precision robotic surgery

Telemedicine

Targeted drug delivery systems

Lab-on-a chip

Regenerative Medicine

In-vivo nano-imaging

Cell therapies

Artificial Organs

Information Technology

Biological sciences

Materials sciences

Imaging Technology


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MEDICAL DEVICEBorderline Issues

Other products

Medicinal

products

Biocides

MD

IVMD

Cosmetics

Individual

protection

equipment


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MEDICAL DEVICEBorderline Issues

Is this product a medical device ?

MD

  • Medical purpose

  • Principal intended action


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MEDICAL DEVICEBorderline Issues

Analysing Tools

  • Labelling / Instruction for use

  • Technical documentation

  • Pre-clinical and clinical studies

  • Enquiries

  • Classification/Demarcation guidelines


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MEDICAL DEVICE

High Risk

Medium Risk

Low Risk

Source, EUCOMED

400.000 Medical Device Types

10.000 Families


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MEDICAL DEVICES DEFINITION includes devices for “In Vitro” examination

  • Reagent

  • Reagent Product

  • Kit

  • Calibrator

  • Control Material

  • Instrument

  • Apparatus

  • Equipment

  • or system


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MEDICAL DEVICES DEFINITION includes devices for “In Vitro” examination

  • … and sample collection, specimen receptacles and storage devices.


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MEDICAL DEVICE DEFINITION includes devices for “In Vitro” examination

  • ...to provide information :

  • Concerning a physiological or pathological state;

  • Concerning a congenital abnormality;

  • To determine the safety and compatibility with potencial recipients;

  • To monitor therapeutic measures


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Thank You


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  • Study Group 1

  • Essential Principles

  • of

  • Safety and Performance

  • of Medical Devices

M. Gropp

GHTF SG-1

AdvaMed, Eucomed

Guidant Corporation

Brussels, Belgium


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GHTF SG-1: Essential Principles of Safety and Performance of Medical Devices

Only medical devices that are safe and perform as

intended should be allowed in the market

 Agree

 Disagree


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GHTF SG-1: Essential Principles of Safety and Performance of Medical Devices

  • Presentation overview

    • Introduction

    • Purpose

    • Overview of main points of Essential Principles guidance document


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GHTF SG-1: Essential Principles of Safety and Performance of Medical Devices

http://www.ghtf.org/index.html


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GHTF SG-1: Essential Principles of Safety and Performance of Medical Devices


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GHTF SG-1: Essential Principles of Safety and Performance of Medical Devices


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GHTF SG-1: Essential Principles of Safety and Performance of Medical Devices


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GHTF SG-1: Essential Principles of Safety and Performance of Medical Devices

  • Document history

    • “The GHTF has identified as a priority the need to harmonize essential safety and performance criteria for a medical device that allow the manufacturer to demonstrate its product is suitable for its intended use.

    • This goal was achieved through the publication of guidance on the subject entitled Essential Principles of Safety and Performance of Medical Devices (SG1/N020 of June 30, 1999) that applied to the majority of medical devices but not to in vitro diagnostic devices. …”


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GHTF SG-1: Essential Principles of Safety and Performance of Medical Devices

  • Document history

    • “…. This current document supersedes that earlier one. The major difference between them is the expanded scope; this document now includes medical devices for the in vitro examination of specimens derived from the human body.”


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GHTF SG-1: Essential Principles of Safety and Performance of Medical Devices

  • Rationale

    • “Consistent identification, selection and application of safety and performance principles to a medical device offers significant benefits to the manufacturer, user, patient or consumer, and to Regulatory Authorities since it allows its manufacturer to design, manufacture and demonstrate the device is suitable for its intended use. ...”


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GHTF SG-1: Essential Principles of Safety and Performance of Medical Devices

  • Rationale

    • “… Moreover, eliminating differences between jurisdictions decreases the cost of gaining regulatory compliance and allows patients earlier access to new technologies and treatments.”


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GHTF SG-1: Essential Principles of Safety and Performance of Medical Devices

  • Scope

    • “This document applies to all products that fall within the definition of a medical device that appears within the GHTF document Information Document Concerning the Definition of the Term “Medical Device”, including those used for the in vitro examination of specimens derived from the human body.”


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GHTF SG-1: Essential Principles of Safety and Performance of Medical Devices

Source: GHTF


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GHTF SG-1: Essential Principles of Safety and Performance of Medical Devices

  • Purpose

    • “To describe six general requirements of safety and performance that apply to all medical devices.

    • To provide a comprehensive list of design and manufacturing requirements of safety and performance, some of which are relevant to each medical device. …” [emphasis in original]


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GHTF SG-1: Essential Principles of Safety and Performance of Medical Devices

  • Purpose

    • “… These are grouped as:

      • Chemical, physical and biological properties

      • Infection and microbial contamination

      • Manufacturing and environmental properties

      • Devices with a diagnostic or measuring function

      • Protection against radiation

      • Requirements for medical devices connected to or equipped with an energy source

      • Protection against mechanical risks …


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GHTF SG-1: Essential Principles of Safety and Performance of Medical Devices

  • Purpose

    • “… These are grouped as: (continued)

      • Protection against the risks posed to the patient by supplied energy or substances

      • Protection against the risks posed to the patient for devices for self-testing or self-administration

      • Information supplied by the manufacturer

      • Performance evaluation including, where appropriate, clinical evaluation”


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GHTF SG-1: Essential Principles of Safety and Performance of Medical Devices

  • Purpose

    • “The manufacturer selects which of the design and manufacturing requirements are relevant to a particular medical device, documenting the reasons for excluding the others.

    • The Regulatory Authority and/or Conformity Assessment Body may verify this decision during the conformity assessment process.” (or audit)


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GHTF SG-1: Essential Principles of Safety and Performance of Medical Devices

Source: GHTF


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GHTF SG-1: Essential Principles of Safety and Performance of Medical Devices

  • General requirement 1

    • “Medical devices should be designed and manufactured in such a way that, when used under the conditions and for the purposes intended and, where applicable, by virtue of the technical knowledge, experience, education or training of intended users, they will not compromise the clinical condition or the safety of patients, or the safety and health of users or, where applicable, other persons, …”


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GHTF SG-1: Essential Principles of Safety and Performance of Medical Devices

  • General requirement 1 (continued)

    • “… provided that any risks which may be associated with their use constitute acceptable risks when weighed against the benefits to the patient and are compatible with a high level of protection of health and safety.”


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GHTF SG-1: Essential Principles of Safety and Performance of Medical Devices

  • General requirement 2

    • “The solutions adopted by the manufacturer for the design and manufacture of the devices should conform to safety principles, taking account of the generally acknowledged state of the art.

    • When risk reduction is required, the manufacturer should control the risk(s) so that the residual risk(s) associated with each hazard is judged acceptable.…”

      • Reference: ISO 14971:2001: Medical devices – Application of risk management to medical devices


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GHTF SG-1: Essential Principles of Safety and Performance of Medical Devices

  • General requirement 2 (continued)

    • “The manufacturer should apply the following principles in the priority order listed:

      • identify known or foreseeable hazards and estimate the associated risks arising from the intended use and foreseeable misuse,

      • eliminate risks as far as reasonably practicable through inherently safe design and manufacture

      • reduce as far as is reasonably practicable the remaining risks by taking adequate protection measures, including alarms,

      • inform users of any residual risks”


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GHTF SG-1: Essential Principles of Safety and Performance of Medical Devices

  • General requirement 3

    • “Devices should achieve the performance intended by the manufacturer and be designed, manufactured and packaged in such a way that they are suitable for one or more of the functions within the scope of the definition of a medical device applicable in each jurisdiction.”


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GHTF SG-1: Essential Principles of Safety and Performance of Medical Devices

  • General requirement 4

    • “The characteristics and performances …. should not be adversely affected to such a degree that the health or safety of the patient or the user and, where applicable, of other persons are compromised during the lifetime of the device, as indicated by the manufacturer, when the device is subjected to the stresses which can occur during normal conditions of use and has been properly maintained in accordance with the manufacturer’s instructions.”


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GHTF SG-1: Essential Principles of Safety and Performance of Medical Devices

  • General requirement 5

    • “The devices should be designed, manufactured and packed in such a way that their characteristics and performances during their intended use will not be adversely affected under transport and storage conditions (for example, fluctuations of temperature and humidity) taking account of the instructions and information provided by the manufacturer.”


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GHTF SG-1: Essential Principles of Safety and Performance of Medical Devices

  • General requirement 6

    • “The benefits must be determined to outweigh any undesirable side effects for the performances intended”


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GHTF SG-1: Essential Principles of Safety and Performance of Medical Devices

  • Conformity assessment

    • “Refer to … Principles of Conformity Assessment for Medical Devices and the work of GHTF Study Group 5 for further information on the use of clinical evaluation to demonstrate compliance with these Essential Principles.”


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GHTF SG-1: Essential Principles of Safety and Performance of Medical Devices

  • Summary

    • Essential Principles form foundation of harmonised global regulatory model

    • Comprehensive in scope

    • Cover safety and performance

    • Define design requirements

    • Do not define methods of achieving, demonstrating, or documenting conformity

      • Often covered by international standards


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GHTF SG-1: Essential Principles of Safety and Performance of Medical Devices

  • Summary

    • Flexible to accommodate advances in the state of the art and new medical devices / technologies / intended uses

    • Recognise risks and benefits associated with medical devices

    • Are founded on risk management principles

    • Intimately linked to manufacturer’s quality system for design, manufacture, and risk management


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GHTF SG-1: Essential Principles of Safety and Performance of Medical Devices

Questions?


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Study Group 1

STED

Summary Technical Documentation

Peter W.J. Linders

GHTF SG-1

COCIR

Philips Medical Systems

Best, The Netherlands


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STED

  • What is STED ?

  • How is STED developed ?

  • What’s in STED ?

  • Use of standards (brief)

    Inspired by Johan Brinch & Ed Woo, APEC Bangkok 2005


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STED

  • STED=Summary Technical Documentation

  • Used for demonstrating conformity to the Essential Principles of …

  • Safety & Performance of Medical Devices

  • STED=information considered sufficient for regulatory agency to confirm conformity


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STED

  • Remember, STED is a

    Summary Technical Documentation,

    not …


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STED

GHTF identified the need to harmonize documentation

of evidence of conformity to regulatory requirements

  • MD manufacturers increasingly global

  • Differences in documentation requirements

    • Necessitate additional work for the same device

    • Hinder timely access to medical devices

    • May pose barriers between countries

    • Increase cost

  • International standardization good for all parties


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SPECIFY DEVICE’S INTENDED USE

DEVICE

CLSSSIFICATION

IDENTIFY RELEVANT ESSENTIAL

PRINCIPLES of

SAFETY & PERFORMANCE

DESIGN & MANUFACTURE DEVICE TO

MEET ESSENTIAL PRINCIPLES

VERIFICATION

THROUGH

INDEPENDENT

AUDIT

DEMONSTRATE COMPLIANCE

(if required)

THROUGH TESTING, MEETING

REQUIREMENTS OF STANDARDS, OR

THROUGH CLINICAL EVALUATION etc.

RISK ANALYSIS/

MANAGEMENT

FULL TECHNICAL

DOCUMENTATION

SUMMARISED TECHNICAL

INFORMATION

PLACE SAFE DEVICE ON THE MARKET

MANUFACTURER’S

REGULATORY OVERSIGHT

POST-MARKET

AND ENFORCEMENT

SURVEILLANCE

VIGILANCE

REPORTS

Source: GHTF website (amended)

STED

Global Regulatory Model

SUMMARISED

TECHNICAL INFORMATION


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Global Regulatory Model

FULL TECHNICAL DOCUMENTATION

SUMMARISED

TECHNICAL INFORMATION

PLACE SAFE DEVICE ON THE MARKET

STED

Zoom-in on essential part …


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Quality System

Postmarket

vigilance

Pre-market approval

Verification/

Validation

Design

Manufacture

Market

Quality System Audit

STED

Harmonised Regulatory Model

SUMMARY

TECHNICAL DOCUMENTATION


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STED

Design Control Waterfall Model

QUALITY SYSTEM DESIGN PROCESS GUIDELINE

PROCESS OUTPUTS

Technical

Requirements

Device

Description

Verification and

Validation

Documents

Production,

Process &

Other docs.


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STED

Source and Application

QUALITY SYSTEM OUTPUT

SUMMARYDOCUMENTATION

USAGE

Pre-market

Submitted

and/or

on file

Technical

Requirements

DataSubset

Device

Description

DataSubset

Summary

Technical Documents

Post-market

Available

for audit

Verification &

Validation

Documents

DataSubset

Production,

Process &

Other docs.

DataSubset


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STED

Summary Technical Documentation

Device description

Essential Principles: evidenceof conformity

Labelling

Risk analysis (riskmanagement)

(pre-)clinical design verification & validation

Manufacturing information


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Detail of

the Contents of Data

Class D(Ⅳ)

Class C (Ⅲ)

Class B (Ⅱ)

Novelty of

Medical Device

Assess the Conformity

to Standards

Assess Validity and Safety

from the Examination Results etc.

Require Clinical data

STED

STED & amount of information


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STED

  • Again, STED is a

    Summary Technical Documentation,

    not …


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STED

Device description

  • 7.2 Device description

  • functional purpose

  • general description of the device

  • the intended patient population(s)

  • contraindications

  • an explanation of any novel features

  • the accessories

  • the variants of the device

  • comparisons to other devices


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STED

Device description (2)

  • materials and their physical properties  

  • functional characteristics

  • technical performance specifications

  • chemical, physical, electrical, mechanical, biological, software, sterility, stability, storage and transport, and packaging


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STED

Essential Principles and evidence of conformity

7.1 Essential Principles

For ease of use in a global situation, it is recommended that the evidence of conformity be provided in tabular form with supporting documentation available for review as required


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STED

Essential principles checklist


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STED

Labelling

  • 7.4 Labelling

  • Labels on the device and its packaging

  • Instructions for use

  • Other literature or training materials

  • Instructions for installation and maintenance

  • Any information and instructions given to the patient, incl. instructions for any procedure the patient is expected to perform


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STED

Risk analysis

7.5 Risk analysis

The STED should summarize or reference or contain (as determined by need for a submission and the option selected by the manufacturer in Section 6.2) the results of the risk analysis. This risk analysis should be based upon international or other recognized standards, and be appropriate to the complexity and risk class of the device.


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STED

Risk analysis

Can you have full Risk Analysis (or Risk Management) details in STED ???


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STED

Risk analysis

  • Risk analysis/mgt dossier is BIG

  • No prescribed format

  • Links to many other documents

  • Decisions made by manufacturer

  • (How to) interpret all information?


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STED

Risk analysis

  • For the manufacturer

  • Include process description in STED dossier

  • Give actual RM process data for the device

  • For the regulator

  • Verify that RM process IS in place


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STED

Risk analysis

  • For the manufacturer

  • Include process description in STED dossier

  • Give actual RM process data for the device

  • For the regulator

  • Verify that RM process IS in place


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STED

Summary documents of pre-clinical design verification and validation

7.3.1 General on design V&V

declarations/certificates of conformity to the “recognized” standards listed as applied by the manufacturer and/or …

summaries or reports of tests and evaluations based on other standards, manufacturer methods and tests, or alternative ways of demonstrating compliance


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STED

Summary documents of pre-clinical design verification and validation

engineering tests

laboratory tests

biocompatibility tests

animal tests

simulated use

software validation


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STED

Summary documents of (pre-)clinical design verification and validation

7.3.2 Clinical Evidence

The STED should indicate how any applicable requirements of the Essential Principles for clinical evaluation of the device have been met. Where applicable, this evaluation may take the form of a systematic review of existing bibliography, clinical experience with the same or similar devices, or by clinical investigation


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STED

Manufacturing information

7.6 Manufacturer information

The STED should summarize or reference or contain documentation related to the manufacturing processes, including quality assurance measures, which is appropriate to the complexity and risk class of the device


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STED

Regional tailoring

From 2.0: Regional tailoring

  • As an interim measure until full global harmonization of documentation requirements is achieved, the precisecontent of the STED … will need to be augmented by documentation required by country-specific regulations and regulatory guidance

    USA - FDA / Canada - HC / Europe - NB’s /

    Australia - TGA / Japan - MHLW / other - ?


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STED

Regional tailoring

USA - FDA / Canada - HC / Europe - NB’s /

Australia - TGA / Japan - MHLW / other - ?

FDA: http://www.fda.gov/cdrh/ode/guidance/1347.html

HC: http://www.hc-sc.gc.ca/dhp-mps/md-im/activit/int/ghtffs_gthmfd_e.html

http://www.asiahwp.org/Canada_ghtf_sted_guide_e.pdf

EU:no format specified

TGA:http://tga.health.gov.au/docs/pdf/tganws/tganews35.pdf

MHLW: no specific url available


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STED


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STED


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STED

Regional tailoring

USA - FDA / Canada - HC / Europe - NB’s /

Australia - TGA / Japan - MHLW / other - ?

Regulators and industry should jointly evaluate

progress towards harmonization and

adapt processes accordingly:

“continual improvement”


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STED


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Building blocks for harmonized regulatory processes

International Standards


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Use of Standards in conformity assessment(another GHTF SG1 document)

  • Compliance to “Recognized Standard” gives

  • “Presumption of compliance” with Essential Principles

  • Voluntary except when deemed mandatory

  • Manufacturer is free to select alternative solutions to demonstrate compliance

    • National and International standards

    • Industry standards

    • Internal SOP

    • Current state of art techniques related to performance, material, design, processes


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Standards in STED

  • In STED, in lieu of technical doc. submission

  • Declarations, certificates, summary test report

  • Retain documentation to demonstrate device compliance to selected standard or other means to meet Essential Principles

    • How standard was applied with test results.

    • Deviations

      • other means to compliance

      • when not applicable


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Standards in development

  • ISO, IEC, … are global bodies

  • Use defined consensus mechanism

  • All stakeholders involved

  • Stepwise development process:

    • NWIP / CD / CDV or DIS / FDIS / IS

  • Maturation process, usually > 3 years

  • Voting process includes national committees

  • Great help in global convergence !!


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Standards in development

A few well known examples:

  • ISO 13485: Quality Mgt. System for medical device manufacturers

  • ISO 14971: Risk Mgt. for medical devices

  • IEC 60601-1: Safety & Essential Performance for medical electrical equipment


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Revision or Replacement of Recognized Standards

  • Updated standard becomes “recognized” too

  • Transition Period

    • Should allow for manufactures to implement

    • Max < 5 years; unless exceptional circumstances

  • During Transition Period

    • Both versions give presumption of conformity to EP

    • Unless safety implication, devices on market is OK

  • After Transition Period

    • Superseded document may be withdrawn

    • Manufacturer using superseded version may do so but should perform & document risk assessment on differences


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Summary on standards

  • Standards compliance is one means to demonstrate compliance to Essential Principles

  • Transition to revised version important

  • Standards enforcement flexibility should be allowed

  • International standards key in harmonization

  • Economies may want better participation in development and use of international standards


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STED

Final comments

  • STED is a compilation of a subset of documents normally generated during the design process

  • Size of the STED dossier is proportional to the risk class of the device

  • Some regional tailoring is still here …


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STED

Thank you for your attention


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