RA/QA

Regulatory Affairs and Quality Assurance

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, ISO27001 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.

A selection of the services we provide. Per project, we will tailor our services to your needs.

Introduction training

(This service is usually provided as a standard for each new project)

An introduction to CE-marking of Medical Devices via videoconference or on-site presentation.

Customized overview of the applicable European Medical Device Regulations as it relates to the manufacturer’s devices.

Prior to the conference, to ensure its time-efficiency, we provide a printable copy to make notes during the presentation and the manufacturer provides CEpartner4U with information about the medical devices that need to be CE-marked.

Technical File review

Review of existing Technical File documents, risk classification and conformity procedure of your device to assess compliance with the Regulations.

In advance, the following documents must be provided by the manufacturer:

  • Product details;
  • Documents which conclude compliance with the general safety and performance requirements;
  • Risk analysis;
  • Clinical / performance evaluation;
  • Further technical documentation, including product labels and Instructions for Use.

CEpartner4U will deliver a report with conclusions and recommendations.

CE Entry Pack

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

This program requires active involvement of manufacturer’s personnel.

The technical file will be created according to the IMDRF ToC.

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

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.

Technical file implementation

As an alternative to the CE Entry Pack: CEpartner4U will develop the technical documentation as required by the Regulations.

Includes:

  • Frequent meetings with management and employees to complete missing information;
  • Consultation with suppliers, subcontractors, and distributors;
  • Explanation and discussion with management and employees about technical documentation and requirements under the Regulations;

CEpartner4U will use customized documents from the CE Entry Pack.

Review quality documentation

Review of existing Quality Management System documentation to evaluate compliance with ISO 13485:2016.

In advance following documents must be provided by the manufacturer:

  • Quality Manual;
  • Standard Operating Procedures;
  • Checklists.

CEpartner4U will deliver a review report with conclusions and recommendations.

ISO Entry Pack

A systematic eight-step program provided via e-mail to set up a Quality Management System according to ISO 13485:2016.

This program requires active involvement of manufacturers personnel.

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

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.

Quality Assurance implementation

Implement/adapt the manufacturer’s Quality Management System according to ISO 13485:2016, merging CEpartner4U’s templates and existing documentation/information that CEpartner4U will collect during phone calls and e-mail communication with the manufacturer or during on-site meetings. The existing Standard Operating Procedures and instructions will be included in the system.

Includes:

  • Integration of existing quality documents in CEpartner4U’s format;
  • Business management analysis;
  • GAP analysis;
  • Recommendations for improvement;
  • Completion of missing procedures and documents;
  • Internal Audit.

CEpartner4U will use the existing documentation and our concept handbook, templates, procedures, and documents.

Notified Body Audit guidance

Includes:

  • Guidance and consultancy during the selection of eligible Notified Bodies and request/evaluate proposals;
  • Guidance and consultancy during Audit, and certification process.
  • Preparation and assistance during and after the Notified Body Audit.

 

Beyond the above listed, we can offer services individually tailored to your demand like personalized training, projects, theme days et cetera.