Based on the experience gathered over the years, CEpartner4U has developed two programs to help manufacturers setting up their technical documentation and quality management system. The programs are built on the essence of the Medical Device Regulations and ISO 13485:2016, and are designed in such a way that redundancy is avoided and documentation is kept to a minimum. The Entry Packs are efficient and cost-effective.

CEpartner4U is specialized in the European Medical Device Regulations and ISO 13485:2016. We work together with hundreds of medical device manufacturers, all of them specialized in their specific sector. Chances are high that our consultants have experience with your type of device or device category.

Our consultants carefully track the number of hours spent on each project. Unless agreed upon in advance, all our projects are completed within the stated budget. You are solely charged for the hours spent on your project.

Your documents, certificates and project related files are stored on a secure, ISO 27001 certified data center located in the Netherlands, accessible only to personnel working on your project. Your data is never stored on laptops, desktop computers or portable media. We provide remote access as well as up- and download of large amounts of data.

CEpartner4U holds in strict confidence and never discloses, provides, communicates, or makes accessible to any person or use in any way for CEpartner4U’s own or another’s benefit any confidential information.

 

CE Entry Pack

Technical File assistance: a systematic seven-step program, provided by e-mail to complete the technical documentation as required under the Regulations.

This program requires an active involvement of manufacturer’s personnel.

The technical file will be created according to the STED (Summary Technical DOcumentation).

The steps are designed in such a way that redundancy is avoided, and the amount of documentation is kept to a minimum.

Step overview:

• Product classification and production overview;
• Request information from suppliers;
• Applicable standards and required tests;
• Risk Assessment;
• Clinical Evaluation;
• General Safety and Performance Requirements and supplier/ distributor agreements ;
• Finalizing the Technical File, post-market surveillance, vigilance, labeling, UDI, and DoC.

At each step, you will receive instructions and ready-to-use templates for Standard Operating Procedures and technical documentation.

This program includes our guidance while setting up regulatory agreements with suppliers, subcontractors, and distributors.

 

ISO Entry Pack

A systematic eight-step program provided by e-mail to set up a quality management system under ISO 13485:2016.

This program requires an active involvement of manufacturers personnel.

The steps are designed in such a way that redundancy is avoided, and the amount of documentation is kept to a minimum.

Step overview:

• Resources, personnel, infrastructure and work environment;
• Product realization and customers;
• Design and development;
• Purchasing, production and measuring devices;
• Management responsibility;
• Measurement, analysis, and improvement;
• Requirements for a quality management system;
• Finalizing the quality management system and remaining Standard Operating Procedures.

At each step, you will receive instructions and ready-to-use templates for the quality handbook, Standard Operating Procedures, and other documentation.

This program includes our guidance while setting up regulatory agreements with suppliers, subcontractors, and distributors.