Information about CE mark Medical Device Certificate Consultant PPT (1)

1. CE mark Medical Device Certificate Consultant Operon Strategist

2. Information about CE Marking Certifications CE mark on a medical device or IVDs conforms that the device meets regulatory demand which is necessary to enter into the EU marketplace. A minor error in specialized file may delay your process of getting CE mark for a device. Boost your chances to get CE Marking Certification fluently with Operon Strategist.

3. CE mark Approval process will vary according to the Class of medical device, as per the MDR CE marking Approval correspond of few further things similar as product quality, technical dossier submission to NB, clinical evaluation and so on. numerous medical device manufacturers don’t really read the regulations of EU MDR and they get stuck nearly in the process, which may delay the project to avoid that you need to know where to start and who's right CE marking consultant for you. Operon strategist don’t leave you before, we make sure that our customer should get the CE approval with minimal efforts. We've a well- experienced staff of expert engineers and significant knowledge and familiarity with the CE marking process. We've a wide knowledge of safety standards, product safety assessments, product design and the real- world issues faced by the manufacturing industries. Our CE Mark Consultant assists new medical device manufacturers to launch a new device into the EU market.

4. Why do you need CE Marking? Short answer is, you get to sell in further countries globally thereby adding your footmark exponentially and also it helps in building credibility within doctor’s community in India. Every country follow their own regulatory system, for eg USFDA is for dealing in the US. CE Mark is mandatory to sell medical devices within any of the 32 European Union countries. It also validates that your device comply with all regulations put forward by European Union, which is accepted by numerous other countries too. However CE mark is accepted by numerous countries and hence investment can be justified fluently.

5. Medical Device Directive is one of the most complex directive and one which involves strict alert by the European Authorities. way for CE marking for Medical Devices of Class 1s, IIa, IIb and III are as follows ● Apply a quality operation system ISO 134852012 as per annex II & V of MDD( not needed for class I non sterile non measuring devices). Appoint an European authorized representative( needed by non EU manufacturer only). Apply General & product specific norms as applicable to the medical device particularlyBio-compatibility( ISO 10993 series for Implants and IEC 60601 series for Electromedical products). Prepare a technical file comprising of detailed manufacturing process, devices description, test reports, risk analysis, Instruction for Use, labeling, applicable normsetc. Submit the specialized file & QMS documents to notified body for approval. Notified Body conducts onsite inspection through approved adjudicators. Restate IFUs & labels to the original language of the country to which you want to export. ● ● ● ● ● ●

6. Operon Strategist For more information about Medical Device Regulations please feel free to contact : enquiry@operonstrategist.com Or Visit : https://operonstrategist.com Call Us Now : 9028043428 | 9370283428 | 9325283428 Address: Office 14, 4th Floor, MSR Capital, Morwardi Road, Pimpri Colony, Pimpri, Pune 411018 Thank You !