Services
Medical Devices
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.
CE Mark Cert
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 to demonstrate its ability to manufacture medical devices / In-vitro diagnostic devices and related services that consistently meet customer and applicable regulatory requirements. Our experienced team can devise an appropriate Quality System for you and ensure you meet the ISO 13485 standard.
EUAR
EU Authorised Representative Service
In accordance with European Regulation, a European Authorised Representative is required for manufacturers of medical devices and IVDs who are located outside of Europe. Acorn Regulatory has been supporting medical device manufacturers located outside of Europe as their Authorised Representative for over a decade, including the USA, Asia and The UK. Located in Ireland, we are registered with HPRA as an economic operator and have our unique single registration number (SRN) from Eudamed.
PRRC
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 details 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. For micro and smaller manufacturers (i.e. <50 employees), Acorn Regulatory can act as your PRRC.
Vigilance
Post Marketing Surveillance & 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. “