Quality & Regulatory

Quality Assurance (QA)
Amkanow can assist with all quality matters related to medical devices.

• Develop bespoke Quality Management System (QMS) for ISO compliance
• Performing internal and external audits
• Review and recommend remedial action plan to address CAPA

Regulatory Affairs (RA)
Amkanow can be your UK Responsible person.

• Registration of your medical devices in the “Device registration system” with the MHRA.
• Manages requests from the MHRA.

Amkanow can assist with trouble shooting to resolve regulatory roadblocks.

• Negotiation and Resolution with Notified Bodies (or Competent Authorities) regarding Technical File challenges.
• Conduct Clinical Evaluations Reviews (CERs)
• Conduct Biological Evaluation Reviews (BERs)