Requirement Mapping Medical Device Regulation (MDR) Document Section Annex VIII (All) Associated Documents: Intended Use SOP Product Certification and Registration Overview Product: (Enter content) Version: (Enter content) Classification: (Enter content) Rule: (Enter content) Justification for classifying the product as a […]
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EC Declaration of Conformity Manufacturer \ \ Medical Device \ \ \ Classification Medical Device Class: \ Classification determined in accordance with \. Reference Art. 51 MDR, Section 1, to identify the applicable classification rule. These are detailed in Annex
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Essential Requirements MDD (93/42/EEC) This document addresses all essential requirements outlined in Annex I of the MDD. Unlike other templates, the quoted sections below directly reference the MDD, without added explanations. These excerpts represent legal text from the MDD itself,
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> Please note that this template includes provisions specific to Germany, referencing the German Federal Data Protection Act (BDSG). Companies based outside Germany should adjust the content accordingly before using the template. As part of your role, you may be
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\ – Technical and Organizational Safeguards 1. General Considerations This document outlines the technical and organizational measures established for the secure and compliant handling of personal data. It takes into consideration the rights of data subjects and aligns with Articles
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1. Overview This checklist is used to verify the completeness and consistency of the Clinical Evaluation Report against the requirements outlined in Appendix A10 of the MEDDEV 2.7/1 revision 4 Guideline. Note: This checklist is sourced from Appendix A10 of
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The Clinical Evaluation Plan outlines the methods for developing and updating the Clinical Evaluation Report. This plan is revised as needed by post-market clinical follow-up, such as when new search criteria are added for literature searches. Although the content of
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Transfer this table to an Excel sheet for better literature management. Adjust it to meet your specific needs and requirements. Search Category No. Reference Potentially Relevant? Relevant After Full Text Review? Title PUI/PMID Abstract Comments Device Name / Equivalent Device
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SS Innovations, the trailblazer behind India’s groundbreaking SSI Mantra Surgical Robotic System, has reached a significant milestone in the field of medical science by becoming the inaugural company in India to obtain approval from the Central Drugs Standard Control Organization
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Inventurus Knowledge Solutions Limited (referred to as the “Company”) is set to launch its initial public offering (“IPO”) of equity shares (termed as “Offer”) on Thursday, December 12th, 2024. The date allocated for Anchor Investor Bidding is Wednesday, December 11th,
IKS Limited’s IPO Scheduled to Begin December 12th, 2024 Read More »