We are pleased to introduce Europlaz’s new Regulatory Affairs Manager, Alastair Fry. Alastair will now be all customers main point of contact for all regulatory enquiries going forward.
As Europlaz’s Person Responsible for Regulatory Compliance (PRRC), Alastair is responsible for ensuring compliance with the MDR/IVDR requirements. This includes device conformity assessments, technical documentation, EU declarations of conformity, post-market surveillance obligations, and the reporting of serious incidents and field safety corrective actions (FSCAs).
What’s more, Alastair is hoping to grow the Regulatory department at Europlaz and use our experience and expertise to help customers navigate the MDR as efficiently as possible.
Having joined Europlaz only recently, Alastair brings over 10 years regulatory affairs experience, with a particular focus on both EU MDR and the UK MDR 2002 (as amended) He has worked across a range of medical device classes, supporting legal manufacturers as well as acting as the UK Responsible Person for manufacturers based outside of Great Britain.
David Bacon, our previous Regulatory Affairs Manager, has now retired.
If you have any questions or require any advice or assistance, please don’t hesitate to get in touch.
