European Device Solutions Limited services
CE Marking Services
We have worked with numerous SMEs and Start Ups to develop their Quality Management System (QMS), Technical File and Risk Management Documentation to help them attain a CE Mark for their new medical device(s) in both a timely and cost-effective manner. We have experience of working with all classes of medical device (Class I, IIa, IIb and III) across a wide range of product types. Software as a Medical Device (SaMD) is a specialism as we have helped numerous clients classify the device (under Rule 11 of the new Medical Device Regulation) and prepare the relevant documentation to ensure compliance with the new MDR, IEC 62304 and ISO 27001.
EU MDR Transition Services
The new Medical Device Regulation (MDR) comes into force on the 26th May 2021 replacing the Medical Devices Directive (MDD) and the Active Implantable Medical Devices Directive (AIMDD). The MDR applies to all manufacturers selling medical devices into Europe and requires them to update both their processes and technical documentation to satisfy the new requirements. The MDR introduces greater scrutiny of technical documentation, clinical evaluations, post-market clinical follow-ups (PMCF) and demands end-to-end traceability of medical devices through the supply chain. All new medical devices introduced to the market after the May 2021 deadline must conform to the new MDR. We will help you ensure your medical devices remain compliant and able to be sold in the EU.
Post Brexit Solutions Services
After the UK formally left the EU (BREXIT) on 31st December 2020, the UK ceased to be recognised as a full EU member state by the remaining EU members. Therefore, to comply with the EU Directives / Regulations for CE Marking, a UK device manufacturer must designate an Authorised Representative (AR) based within a full EU member state, to register their devices with their local Competent Authority. We have an office in Cork, Ireland who can act as your AR, registering your company and devices with the Irish Competent Authority (HPRA).
Software Quality Assurance Services
We are a leading supplier of Software Quality Assurance and Regulatory Advice to industry and academia with many years’ experience in FDA, EMA, & MHRA regulated life sciences industries in the UK, Ireland, US, Far East and the EU. Our services include the following devices: Medical devices (and accessories), In-vitro diagnostic devices (and accessories), Wellness / lifestyle devices, Software as a medical device (SaMD) including mobile, web and cloud-based applications. We are the foremost provider of Software Quality Assurance to the emerging digital healthcare industry as a one stop solution to companies who seek to have medical devices that are solely/predominantly software through registration for CE Mark or FDA approval.
Market Access & Compliance Services
To enter US, Canadian, Brazilian, Japanese, or Australian markets you will need be in compliance with Medical Device Single Audit Program (MDSAP) requirements. MDSAP enables a certification body to perform a single regulatory audit of your company to ensure you comply with the relevant requirements of the participating regulatory authorities. We will conduct a gap analysis on your Quality Management System (QMS) to identify any non-conformities before producing a report you can use to upgrade your QMS or if you prefer, we can complete this project on your behalf.