Here, you can access essential information on various topics related to UKCA certification, ISO 13485,compliance and regulatory requirements and much more. These documents provide valuable insights into certification processes, audit procedures, impartiality policies, and more.
Download the relevant Client Information Notes (CIN) below to access detailed information on your topic of interest.
Abridged Route to UKCA Certification
Certification
Change Notification Medicinal Substance
Complaints and Appeals
FAQ
ISO 13485
Multisite Audits
Policy on Impartiality and Independence
Registration of Medical Devices with MHRA
Remote Assessment
Reporting a Conflict of Interest
Requests for Information
Scope of Services and Areas of Operation
Technical Documentation Review
Transfer of Accredited ISO 13485 Certification
UK MDR
UKCA Conformity Assessment under UK MDR
UKCA Submission Checklist for Medical Devices
UKCA Technical Documentation Submission Guidance
Unannounced Audit Guidelines for Clients
Using the DQS Approval Mark
Witnessed Audits