Regulatory Affairs and Quality Assurance

Consultancy and assistance regarding the requirements in European Directive for medical devices and ISO 13485:2012, regarding:


  • Annual review / internal audit of the technical documentation and quality system documents
  • Medical Device Directive interpretations and clarifications
  • Handling of complaints and incident notifications
  • Provide updates about amendments/changes to the Directive or MEDDEV Guidance documents
  • Requests received from Competent Authority with regard to manufacturer’s obligations under the directive

approximately 16 hours/year, support via phone, fax or e-mail; annual visit on site

ongoing, annual renewal


CE-marking Medical Devices, an introduction on location or by phone-conference.

Prior to the presentation, to ensure the efficient use of everybody’s time we provide you a booklet that will assist the attendees to follow along in the telephone presentation; you will provide CEpartner4U with detailed information about the medical devices that need to be CE-marked.

Customized overview of the European medical device directive as they relate to the manufacturer’s device(s)

Presentation overhead-slides with summarized information
(overhead projection or PowerPoint presentation; send by e-mail, fax and/or priority-mail)

Presentation, 1 – 2 hour
follow-up period for CE-questions received by phone, e-mail or fax: 1 month

Quality Assurance System guidance

Guidance and Consultancy during the implementation of CEpartner4U’s EN ISO 13485:2012 quality system draft documents by your employee(s)

Explanation in customizing CEpartner4U’s draft quality manual, including related procedures and supplier’s agreements

Draft quality manual (English language), draft procedures and draft letter for your supplier(s). Local visits every month are included.

Implementation period, 2 – 4 months

Quality Assurance implementation (only in combination with above service)

Customizing for your company CEpartner4U’s quality manual format, using manufacturer’s existing documentation and information that CEpartner4U will receive during phone meetings and e-mail with your employees or during interviews at location with your employees. Existing procedures and instructions will be included in the Quality Management system.
  • Implementation of your existing Quality documents in CEpartner4U’s quality system
  • GAP-analysis
  • Recommendations for improvement
  • Add missing documents
Customized quality manual, procedures and work instructions which meet the EN ISO 13485:2012 standard
6 days during implementation period of 2 –4 month

Internal audit

Prepare and conduct an internal audit together with manufacturer’s internal auditor(s), if available
Internal audit according manufacturer’s Internal audit planning and procedure
Internal audit report with findings and corrective and preventive actions
1 day on site