In the last couple of years, the medical device industry has seen record numbers of mergers and acquisitions. When a company merges or gets acquired by another, an integration plan needs to be defined taking into account the regulatory and quality aspects of this transition. Too often, those items are overlooked and compliance to the medical device requirements can be challenged. Transferring from Notified Body A to Notified Body B sometime impacts an entire production line of complex devices or even reshapes the entire Quality Management System of an organization. Engaging earlier in a discussion with your Notified Body can help you redefine your plan and avoid any pitfall.
You can tune in to LNE/G-MED North America’s upcoming free webinar and hear Monir El Azzouzi, Quality and Regulatory Compliance Manager at Johnson & Johnson and our Legal and Regulatory Director at LNE/G-MED, Sarah Stec discuss Medical Device Compliance during Merger and Acquisition and the role of Notified Bodies during the transition.
The topics covered in the webinar include:
- Due Diligence and review of the Notified Body
- The crash test phase of the Merger & Acquisition
- Merger & Acquisition Planning
- What Notified Bodies need to know
- QMS integration plans