Our skilled consultants offer a full range of quality assurance and regulatory services for Medical Devices, In Vitro Diagnostics (IVD), Companion Diagnostics (CDx) and Software as Medical Device (SaMD), or Drug Device Combination products (DDC) at all stages of a products life cycle.
We have experience from working with companies of all sizes and business phases, from early startups to large, international organizations.
Regulatory News and Changes
MDR and IVDR is changing the regulatory field of EU. This is challenging for both new and established products. We can support your transition to MDR and IVDR by assessing of your technical documentation, to identify gaps and help you develop a plan for how to close them.
Even established organizations need help from time to time and with our support you can implement, adapt, or maintain a quality system and processes compliant to both regulations and standards such as ISO 13485, ISO 14971 or ISO 9001.
EU Economic Operators
The new European regulations MDR and IVDR include new requirements for all economic operators (legal manufacturers, authorized representatives, distributors, and importers).
We can help you meet these new requirements through development of a regulatory- and business strategy, adaptions of your quality management system, international- or domestic auditing of business partners for MDR/IVDR compliance or training, tailored to your needs and current level of competence.
EU Person Responsible for Regulatory Compliance (PRRC)
MDR and IVDR require all manufacturers and authorized representatives to have a person responsible for regulatory compliance (PRRC) within their organization.
A PRRC must meet requirements for qualification and previous experience, as set out in the regulations. For smaller organizations, we can act as EU PRRC on your behalf, both under MDR and IVDR.
Please contact Jennie Andersson for more information