Quality Management

Quality is the most important aspect in the (pre-)clinical development stage to assure a safe, effective and controlled clinical product. Medace offers quality support in every stage of the development both on a strategic and operational level.

Our overarching Quality Management system is at the heart of everything we do at Medace. It defines start and endpoint of responsibilities and sets the requirements and criteria for the quality level of all other elements you need such as infrastructure, equipment, training and personnel.

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We do this by offering:

Controlled excluded processes/procedures

An ISO13485 compliant QMS including controlled excluded processes/procedures for our Clients.

An ISO13485 compliant work environment

An ISO13485 compliant work environment that meets the quality standards to develop and produce for application in man.

Support

Support via professionals and trainings.

Guidance and support with the QMS

Guidance and support in how to set up and maintain the Quality Management System (QMS) for Clients’ concept or product in line with the used standards and conform regulations.

Providing training

Providing training on project management, risk management, regulations, equipment, processes, etc.

Other Capabilities