Quality management systems for health technology​

When you need Quality Management Systems (QMS) in place at every step of the product life cycle for your medical devices (MD) and in vitro diagnostics (IVD) medical devices, you can turn to DRA for help. Our comprehensive services include establishing, documenting, implementing, maintaining and auditing your QMS, as well as providing a Quality Specialist or a Person Responsible for Regulatory Compliance (EU PRRC). We can assist you with both internal and external audits of your supply, production and distribution chains, and outsourced partners.

Our QMS services for MD and IVD devices include:

  • Establishment of QMS​ (ISO 13485, GMP, GDP)
  • Quality Management audits​ (internal, supplier, support on 3rd party audits)
  • Writing of procedures or other quality documentation
  • Personal leasing
  • Person Responsible for Regulatory Compliance (EU PRRC).

Having your QMS in order and correctly documented is essential before you apply for registration and place your device on the market, as well as for obtaining CE markings. Our team can conduct audits and support you in establishing, documenting, implementing and maintaining your QMS. This includes preparing and submitting documentation to meet the requirements of ISO 13485, GMP, and GDP, as well as compiling reports and plans. Our team will also ensure that your QMS documentation complies with the relevant guidelines, and that it meets the requirements of national authorities like Fimea.​

​We can support your company during the 3rd party audits, and we can also support you with internal audits, as well as helping you to develop your Standard Operating Procedures (SOP). For companies that have products that may fall under pharmaceutical or health technology regulations, or both, we have the knowledge to combine requirements from both areas and ensure that your QMS is valid according to applicable requirements.