Exciting times at #confinis! We are adding on a new affiliation, which brings to you "smarter clinical project management".
Check out www.confinis-cpm.com and get in contact with Autumn Lang and Carin Nilsson.
Beat U. Steffen, Founder and CEO of confinis was invited to speak at the 2018 Combination Product Workshop taking place on 10 October 2018 in Orlando, FL, organized by PDA. It will take place the day after the 2018 PDA Universe of Pre-Filled Syringes and Injection Devices (https://bit.ly/2pax9vA) which brings together industry and regulatory experts to share their experiences, new developments, regulatory considerations, challenges, and industry trends in this exciting area.
The title of his presentation is Medical Device Regulation (MDR, Article 117): Impact on Pharma and Biotech Companies and Related Survival Strategies. It will cover the following topics:
- Regulatory pathway for drug-device combination products in Europe
- What means single-integral?
- Article 117 and ist effect on different drug-device combination products
- General Safety and Performance Requirements (GSPR)
- Survival strategies
Beat will provide this speech based on his vast experience as a consultant for combination product manufacturers as well as a Notified Body auditor / technical file Reviewer.
More info and registration: https://bit.ly/2E3VZrE
#PDAPFS #combinationproducts #article117 #confinis #EUMDR
KPMG/RAPS Survey Digs in to Device Makers' EU MDR Preparedness
The outcome of a survey performed by KPMG and RAPS in June 2018 provided evidence that only 21% of the medical device companies have a deep understanding of the MDR and have a strategy for addressing the regulatory changes it will bring. The report is based on responses from more than 200 regulatory and quality professionals at medical device companies around the globe.
More info: https://bit.ly/2zTCjCU
#eumdr #raps #kpmg #medicaldevices #confinis
Whenever we intend to invest in a company that plans to sell medical devices or combination products we involve confinis in our due diligence process to assess the regulatory strategy, verify compliance with applicable regulations and challenge the time required to obtain marketing authorization. confinis’ expertise regarding EU and US requirements in this area is simply unrivaled and their dynamic and entrepreneurial team are a pleasure to work with.
Patrick M. Aisher
Chairman, Kinled Holding Ltd.
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