In the European Union (EU), two significant regulations have been introduced to enhance the safety and effectiveness of medical devices – the In Vitro Diagnostic Regulation (IVDR) and the Medical Device Regulation (MDR).

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Delve into IVDR's Summary of Safety and Performance for crucial insights and compliance essentials. Stay informed with our concise guide. The world of in vitro diagnostics is all about accuracy and reliability. EU IVDR includes a requirement to write a Summary of Safety and Performance (SSP) for Class C and D IVDs.

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Ensure your packaging meets standards with expert packaging validation. Trust us for reliable compliance every time. Packaging validation is a critical aspect of ensuring the safety and effectiveness of medical devices.

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We help you to prepare Medical Device Technical File (MDR) as per the regulatory requirement of EU MDR 745/2017 and submit to notified body for review and approval of CE certification. In Bangladesh, the Directorate General of Drug Administration (DGDA) oversees medical devices registration.

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Conformity Assessment Procedure for Medical Device under the Responsible Model (EU MDR 2017/745 & EU IVDR 2017/746). A medical device manufacturer has to follow Conformity Assessment Procedure before placing the device on the EU Market. These conformity assessment procedures are documented in Article 52 of the EU MDR 2017/745 for Medical Devices & Article 48 of EU IVDR 2017/746 for Invitro Diagnostic Medical Device.

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