The ability to combine our expertise across our teams in both the pharmaceutical industry and the Medical Device industry is one of the strengths that characterises NIRAS.
The new legislation for the Medical Device Regulation (MDR) or 2017/745 The Regulation on Medical Devices came into force on 26 May 2021. This legislation has changed working days of all players who are a part of the supply chain of medical devices.
Has your company reached its goal? We can review your quality system and product portfolio and indicate a safe way to meet the new requirements. We can also help you carry out the work or be in charge of the project management.
We can help systematise efficiently
Compliance with the legislation is "License to operate", but the quality system must support the business. It should not be an obstacle to taking action.
Our consultants have a business understanding and do not only implement processes that meet the legal requirements, but they are also based on how your unique company performs from day to day.
NIRAS’s expertise within Medical Devices
The following is a selection of the expertise we have within Medical Devices:
The European legislation on medical devices is changing. We have extensive experience within MDD, are fully updated on MDR and understand the differences between MDD and MDR. The MDR system is still very new and without precedent from implementations and audits. Our long MDD experience enables us to assess the implementation of MDR.
FDA 21 CFR PART 820
U.S. medical device legislation can seem daunting and a barrier to exporting to the world's largest medical device market. We have experience in expanding the quality system to include American requirements, assisting with inspections and helping companies to lift "Warning Letters" after a failed inspection. MDSAP and the latest version of 13485, however, have made the FDA less daunting.
Quality management for medical devices is the basis for not only the European legislation MDD and MDR, but also MDSAP (Medical Device Single Audit Program). 13485 sets the requirements for the contents of a quality system. We have extensive experience in the design and optimisation of quality systems.
Unique Device Identification (UDI)
The UDI is a new requirement for all medical products according to the MDR. Later EUDAMED will come. We can review the product portfolio and update it with the UDI. Once EUDAMED is implemented, we can specify the interface of your ERP system so that data can be transferred.
Usability Engineering, EN 62366
When developing medical devices, care must be taken that the user does not operate the equipment incorrectly or directly misuses it. We can facilitate workshops and ensure the required documentation for the Usability Engineering File.
In order to CE label a medical device, it must be documented that it is safe and effective. All relevant documentation must be gathered and presented on request by the authorities. Which requirements, what is relevant and how is the documentation designed? We have regulatory experts who can support or prepare the technical file.