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.
 

CIN

Abridged Route to UKCA Certification

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CIN

Certification

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CIN

Change Notification Medicinal Substance

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CIN

Complaints and Appeals

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CIN

ISO 13485

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CIN

Multisite Audits

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CIN

Policy on Impartiality and Independence

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CIN

Registration of Medical Devices with MHRA

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CIN

Remote Assessment

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CIN

Reporting a Conflict of Interest

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CIN

Requests for Information

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CIN

Scope of Services and Areas of Operation

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CIN

Technical Documentation Review

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CIN

Transfer of Accredited ISO 13485 Certification

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CIN

UK MDR

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CIN

UKCA Conformity Assessment under UK MDR

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CIN

UKCA Submission Checklist for Medical Devices

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CIN

UKCA Technical Documentation Submission Guidance

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CIN

Unannounced Audit Guidelines for Clients

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CIN

Using the DQS Approval Mark

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CIN

Witnessed Audits

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