Medical Device File Template - UKCA Marking ISO 13485 Support Compliance: Provide clear documentation

Support Compliance: Provide clear documentation to demonstrate compliance during audits and inspections

How Will This Template Help Your Organization

the authorised representative shall be legally liable for defective devices on the same basis as

How Will the Procedure Benefit Your Organization

such as biological contamination

Medical Device File Template - UKCA Marking ISO 13485 Support Compliance: Provide clear documentationISO 13485 QMS. 4. 2. 3. 1 Medical Device File Template UKCA Marking This medical device template covers the requirements of the UK Medical Device Regulations 2002 for the purposes of UKCA Marking of medical devices. As of June 2023 all medical devices sold into the UK are required to have a UKCA mark technical file. If you would like further information on our wide range of templates or have any suggestions for improvement that require support in