New Device Regulations

Are you looking for help in this challenging regulatory market?

Medical device companies looking to keep their products on the market need to stay in compliance with multiple regulations which have all undergone recent and sweeping changes. The recent changes in MEDDEV, MDSAP, ISO 13485:2016 and MDR are making talent able to address changes more scarce and expensive and compliance work difficult to get done.

Do you know what you will need to accomplish to stay in compliance? Do you know how to gather the needed resources and keep everything on track to be compliant in time for these regulations to be enforced?

Waddell Group provides World Class Project Managers to manage the various expert resources needed to see projects through to completion on time and on budget. We begin with a Gap Analysis for most of the regulatory changes, and craft a smart plan to get your company into compliance. We follow up by managing the team according to that plan to ensure compliance.

If you need help, please contact us here: [email protected]

If you would like to know more about these regulatory changes, check out these blog posts:

Gap Analyses | Overview of Regulatory Changes | MDR | MEDDEV