Join Our Upcoming Webinar

On Tuesday, 16 November 2021 at 11am-12pm ET, RQM+ will host a webinar about the most common challenges related to SSCPs and SSPs and how to overcome them. Fill out the form to register now.

What You Can Expect to Learn

The summary of safety and clinical performance (SSCP) for Class III and implantable medical devices and summary of safety and performance (SSP) for Class C and D IVDs are new requirements that were not included in the MDD or IVDD. Manufacturers creating these documents for the first time have questions, and RQM+ has answers.

This webinar will provide guidance and instruction on:

  • The intention behind the requirement for an SSCP/SSP
  • How frequently the documentation must be updated
  • Who the intended audience is
  • How to interpret the MDR and IVDR requirements
  • How to write an SSCP/SSP

Former notified body leadership will also address the most common challenges and mistakes, including actionable tips for:

  • Presenting the residual risk table, what details to include, and how to validate
  • Determining how much detail meets the requirements without divulging confidential information
  • Aligning SSCPs with CERs and SSPs with PERs
  • Writing content for the patient audience
  • Validating patient content through user surveys, labeling comprehension studies, and other mechanisms

Learning Level

Intermediate: Content is designed based upon the assumption that individuals have basic knowledge of the topic(s) and/or demonstrated competence related to the topic(s). Higher-level concepts are introduced during lectures.

Meet the RQM+ Experts:

jon gimbelJon Gimbel, Ph.D.
Executive Director, Technical Leadership, Clinical & Post-Market Practice

Jon has a Ph.D. in mechanical engineering and more than 20 years of experience with medical devices. Jon is a prominent member of the RQM+ EU MDR and IVDR leadership teams, and also provides expert technical guidance for the company’s clinical practice.

"As a consultant, I’m involved in a wide range of projects which puts me in a position to monitor how regulatory bodies are enforcing the regulations. This enables me to help our clients navigate the gray areas and avoid common pitfalls so they can keep their devices on the market."


kuttiJaishankar (Jai) Kutty, Ph.D.
VP, Clinical Regulatory Services

Jaishankar "Jai" joined the RQM+ clinical team in February of 2021 after seven years at BSI where he held CE marking technical and clinical leadership roles. He is the captain of his underwater bowling team that can also build suspension bridges using floss picks and paper clips. If that means nothing to you, when he is not running with the queen or waltzing with the bulls, he is best at leveraging his unique blend of expertise combining cardiovascular product development and CE marking-experience, towards supporting our clients with regulatory solutions and developing clinical strategies. His fresh-from-the-notified body perspective brings great insights and creative approaches to our clients.

"The paradigm shift in EU regulatory/clinical is real but it isn’t quite like mapping Mars either. Along with the talented, knowledgeable team at RQM+, I’m committed to helping retain legacy devices on the market and ensuring patients can benefit from innovative technologies."


Amie_S

Amie Smirthwaite, BEng, Ph.D.
Senior VP, Intelligence & Innovation

Amie joined RQM+ in March of 2020. A clinical and regulatory affairs expert, Amie has over 25 years of postdoctoral experience in medical devices, spanning new product development, quality and regulatory systems, and clinical data evaluation. She is leading the RQM+ clinical team, following her role as former Global Head of Clinical Compliance at BSI.  Amie developed BSI’s clinical compliance team and lead clinical aspects of successful MDR designation.


Carlos headshot

Carlos Galamba, BSc, MSc
IVD Director

Carlos Galamba joined RQM+ in September 2021 after 7 years at BSI where he was responsible for managing, coaching, and developing a global team of IVD technical experts in his role as a Technical Team Manager. Among many of Carlos’s achievements he was BSI’s first in-house clinician for IVDs where he led the implementation of the BSI clinical oversight process and has made hundreds of CE marking recommendations for IVDs. At BSI he supported and led IVDR Notified Body designations, was responsible for the development of clinical procedures, technical guidance for BSI reviewers and consulted on MDCG draft guidance prior to publication, including for example IVD batch verification, summary of safety and performance, IVD classification rules and performance evaluation for SARS-CoV-2.

 

Fill out the form to register for the webinar