Acorn Regulatory have been supporting medical device companies over the past 15 years, supporting areas of non-compliances following Inspections, assisting with and maintaining and effective and functioning QMS, and supporting companies with their technical documentation as they transition to MDR / IVDR.
CE Mark Certification
Obtaining and maintaining CE Mark Certification can be a complex process. Acorn Regulatory will help you at every stage by determining the correct regulatory pathway for your product; including Notified Body selection and appropriate device classification.
ISO 13485 Certification
Gaining ISO 13485 Certification is essential for any organisation in the Medical Device and IVD sector. Our experienced team can devise an appropriate Quality System for you and ensure you meet the ISO 13485 standard.
EU Authorised Representative Service
European Authorised Representatives are required for non-EU medical device and IVD manufacturers. Acorn Regulatory has been supporting medical device manufacturers located outside of Europe, supporting them with their registrations in EUDAMED
We are industry specialists and EU Authorised Representatives for companies located in The UK, Australia and the USA.
Person Responsible for Regulatory Compliance
The role of QP is a familiar one for those working in the Pharmaceutical sector, but this is the first time in European medical devices legislation that a person is required to be appointed by a manufacturer to take specific responsibility for regulatory compliance of devices. Article 15 of MDR 2017/745 sets out the detail of the person responsible for regulatory compliance. It requires that manufacturers shall have available within their organisation at least one person responsible for regulatory compliance who possesses the requisite expertise in the field of medical devices. Acorn Regulatory can act as your PRRC upon the introduction of the new MDR.
Post Marketing Surveillance and Device Vigilance
Effective post-market surveillance and vigilance systems are legal requirements of your CE Mark Certification. If you are unsure of the vigilance reporting requirements in Europe or need help devising a robust post-marketing surveillance strategy, then we can assist your company. We will ensure that you are compliant with the appropriate European legislation.
Thank you very much for your guidance and expertise in closing out the Inspection findings. Your value to our team is apparent in how quickly this round of queries was closed off. More than that, we all enjoyed working with you and are somewhat looking forward to our next encounter with our Notified Body.