Quality Assurance


With the right Quality Assurance processes in place, you are always ready for an audit. 

We support you in developing and implementing the Quality Management system best fitted for your operations and help you stay one step ahead.

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Quality Assurance experts with focus on service

Our consultants have extensive knowledge and experience in all aspects related to Quality Management and Quality Assurance. We offer support in developing and implementing your quality management system (QMS) in accordance with Medical Device regulation (MDR), In-Vitro Diagnostic regulation (IVDR), ISO 13485 and 21CFR820 (QSR) requirements.

We can act as your company´s Quality Assurance expert and take care of all quality management system related activities (e.g. management review, internal audit, CAPA, supplier audits, control of economic operators).

 

A Quality Management system helps you to focus on the right things at the right time. 

Our services include:

 

 

  • MDR / IVDR Gap Analysis
  • Gap Analysis (eg. ISO 13485, QSR)
  • Establishing a quality management system according to the requirements for medical devices / IVD, including required processes, procedures, instructions and forms
  • Monitoring and adjustment of your QMS
  • Conducting internal, supplier and economic operator audits
  • Preparation for and assistance during external audits
  • Software development acc IEC 62304 and IEC 82304
  • Economic Operator procedures

Contact

Whether you have questions regarding regulations, clinical strategies, educations or need help with an audit, you are always more than welcome to contact us.

Other services offered

Quality Assurance

We support you in developing and implementing the Quality Management system best fitted for your operations and help you stay one step ahead.

Person responsible for regulatory compliance (PRRC)

As EU medical device regulatory affair and quality assurance experts, we fulfill the competence requirements on PRRC in MDR and IVDR and can act as PRRC on behalf of small companies.

EU authorized representative

All medical device manufacturer located outside EU must have an EU Authorized Representative based within the EU. We guide you and can act as your EU Authorized Representative.

Biocompatibility

Within the Biocompatibility and Toxicology field, we support you in selecting the right biomaterial, planning and executing a Biological Evaluation and setting up Toxicology and Risk assessment strategies.