ISO 13485 Certification

1. All facilities engaged in the production of primary packaging materials for medicinal products require a Quality Management System (QMS) for ISO 13485 certification. Developing a comprehensive system to meet all the requirements of ISO 13485 for effective implementation to achieve desired results, a competent ISO 13485 consulting company or a competent ISO 13485 consultant is essential. https://enhancequality.com/standards/iso-134852016-quality-management-practices-in-the-medical- devices-sector/

2. • ISO 13485 QMS consulting companies assure required QMS is developed to comply with all customers and regulatory requirements and the organization can demonstrate that the facility has a robust system and can produce quality products and ensure safety for consumers • ISO13485: 2017 is an international standard dedicated to build QMS for primary packaging of medicinal products and pave way for continual https://enhancequality.com/standards/iso-134852016-quality-management-practices-in-the-medical- devices-sector/ improvement in any facility.

3. • A competent iso 13485 quality management system consulting company or ISO 13485 consultant explanation on the intent of the standard while developing an ISO 13485 Quality Management System(QMS) • A comprehensive QMS can create confidence in government, statutory and regulatory answers to all questions from Regulatory and Certification Body Auditors • An ISO 13485 consulting firm provides the techniques for developing and implementing https://enhancequality.com/standards/iso-134852016-quality- management-practices-in-the-medical-devices-sector/ can provide detailed end users, and provide agencies the QMS

4. • A effectively conduct ISO 13485 conformity audits to fully prepare for ISO 13485 certification audits to ensure implementation • ISO 13485 consulting companies minimize FDA audits and product recalls through robust compliant system development and effective implementation techniques 3rd Party audit Certification Bodies (Accredited by International Accreditation Forum =IAF) perform the audits on the organizations to grant ISO 9001 Certifications conformity to all the requirements https://enhancequality.com/standards/iso-134852016-quality- management-practices-in-the-medical-devices-sector/ consulting firm can provide internal auditing services to or ISO 13485 consultants can with of demonstrated ISO 13485 evidence requirements of .

5. Benefits of Having an QMS for Medical Devices: The benefits of implementing ISO 13485 standard :2016 management systems are diverse and will be seen in all departments of your company. The following are some of the benefits that you should take into consideration: • ISO 134852016 allows your organization to meet the customer requirements in the production of medical equipment. • Provides necessary ideas to standardize quality management in the medical equipment fields. • Certification will reduce or eliminates FDA audits • Well built QMS for medical devices help avoid the need to recall medical devices • Well-built ISO 13485:2016 QMS shows the way to adhere to all statutory and regulatory requirements associated with medical devices. • Certified ISO 13485:2016 companies produce good quality medical devices which help extend human or animal life expectancy • Critical in providing a competitive edge for your organization https://enhancequality.com/standards/iso-134852016-quality-management- sector/

6. https://enhancequality.com/standards/iso-134852016-quality-management-practices-in-https://enhancequality.com/standards/iso-134852016-quality-management-practices-in- the-medical-devices-sector/