MDR– Getting Your Organization Ready on Section 10.4.1 Substances

Live Webinar

  • 90 minutes

The MDR is a comprehensive document in comparison to the MDD. The scope of the MDR is wider than the MDD and includes Active Implantable Medical Devices (AIMD’s). There is a special focus on safety and device vigilance alongside the details on substances i.e. restricted materials related compliance.

Join this session by expert speaker Milind Nadgouda, where he will explain he will discuss the detailed information on the impact of Section 10.4.1 – Substances, Guidance laid out for labeling and new medical device trends.

Session Highlights:

  • EU Medical Device Regulation - Fundamental and timelines

  • Overview of principal requirements

  • Section 10.4.1 - Substances

  • Design and manufacture details

  • Justification of the presence of materials

  • Labeling requirement

  • Section 23.4 (s) - Information in the instructions for use

  • Section 6.2 (d) Additional information

  • Managing Global Restricted Materials Compliance

  • Legacy medical devices

  • New medical devices

Why You Should Attend:

The changes to the rules, the specifics and how to be prepared are key, this webinar will provide insight into the changes that impact. In particular, the restricted materials related compliance including key risk areas with substances; justification for the presence of substances; guidance laid out for labeling.

Who Should Attend:

  • Quality Assurance Personnel

  • Quality Control Personnel

  • Regulatory Affairs Professionals

  • Process Development Scientists and Management

  • Project Managers working in the CMC arena

*You may ask your Question directly to our expert during the Q&A session.

** You can buy On-Demand and view it as per your convenience.

Milind  Nadgouda

Milind Nadgouda

Milind Nadgouda is a seasoned quality and regulatory professional with 19 years of industry experience. He is the Co- founder and Director at RiverArk Limited; a Quality Consultancy providing services in GxP space. His core areas of specialisation are Risk Strategy (Identification; Assessment; Rating; Prevention and Mitigation); Regulatory Agency Inspection Readiness and Quality Management System GAP analysis. Milind has worked on different types of quality projects with methodologies such Six Sigma; Kaizen and Lean. His expertise on quality strategy and regulatory compliance has been derived from hands on real world experience. So far in his career Milind has been in the frontline during GxP inspections and has on several occasions been in the back room supporting the team for inspections. AstraZeneca, Bristol Myers Squibb, Ranbaxy and Eli Lilly are few of the companies Milind has worked at and consulted. He sees himself as a problem solver and a solution provider.

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