Regulatory Affairs consulting - Medical Devices

your fast track to market

Regulatory and Technical Assistance for Class I, II, and III Medical Devices

Class I Devices (including sterile, non-sterile and measuring function)

PDS can provide general pre-CE-marking assistance by reviewing your product, determining its device classification and route to conformance. We can assist with technical file preparation and maintenance. We can provide advice on labels, checking compliance and claims and instructions, and arrange translations. PDA can help ensure QA compliance including operating procedure advice and writing, as needed.

Class II and III Devices

PDS can advise and assist the client with regulatory matters and liaise with the Notified Body from initiation to completion of the CE-marking process. We can prepare (and submit) documentation to support clinical investigations or studies.

Non-EU Device Manufacturers

For Device Manufacturers based outside the European Union, PDS can act as Authorised Representative. In this role, we maintain a watching brief on all matters of concern to the client, including regulatory updates.

Vigilance

PDS will liaise with Competent Authorities in respect of Vigilance matters. We advise, assist, and submit Adverse Incident Reports as required to the relevant Competent Authorities on behalf of our clients.