Medical Device Solutions
Our medical device regulatory affairs experts have a well deserved reputation for excellence with our global client base. The team is staffed by individuals with significant experience in industry and with national authorities.
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.
European Authorised Representative Services
All non-EU medical device and IVD manufacturers must appoint a European Authorised Representative. If you are a non-EU manufacturer and wish to market your device in Europe, Acorn Regulatory can act as your EU Authorised Representative.
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.
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
If you have an issue that you would like our medical device regulatory affairs experts to help you with, then get in touch with us by completing the form below or by calling us on 00353 52 61 76 706.
I am delighted to say that we submitted our application yesterday. I would like especially to thank Acorn Regulatory without whose continuous help, guidance and direction we would not have made the deadline.Senior Quality Systems Manager at a medical device firm in the USA.