Regulatory
Design for Compliance
An understanding of the regulatory requirements for the MHRA in the UK, the EMA in Europe, FDA in the US and so on is critical for route-to-market planning. Even in early stage concept design and feasibility we will have these discussions with you to ensure future compliance is at the forefront of decision-making. Planning should be based on primary and follow-up target markets to comply with medical and in vitro device regulatory requirements in those markets.
And you can still achieve rapid progress in feasibility, concept development, prototyping for demonstration.
Key Concepts in Medical Device Regulation
All medical and in vitro diagnostic devices (IVDs) need to be registered with the MHRA before they can be made available in the market in Great Britain. This requires compliance with the Medical Devices Regulations 2002 legislation, and UKCA marking.
Risk management and quality are two essential concepts when thinking about medtech regulations. ISO 13485:2016 (Quality Management Systems) provides an overall structured approach to quality. ISO14971 provides a Risk Management structure. Both are essential for good manufacturing practice. Compliance with further standards, such as IEC 60601-1, may be required depending on the device.
Rapid Prototyping
We can help you achieve both a design-for-compliance structured design and development whilst managing rapid iterative design and development to work to a MVP (minimum viable product) or prototype.
Depending on the relative complexity certain areas of regulatory compliance are important to build in from the start, whilst others can be addressed at a later, appropriate stage. It just needs a well-thought-through plan.
Our team your team
We work hand in hand with you in whichever area you need support: planning and preparing for MDR and IVDR compliance providing resources, skills, project leadership, product design for compliance know-how, Technical File and STED compilation, preparation for assessment.
Our tried and tested approach will help you get to market-readiness quickly and efficiently.
By monitoring changes in the medical and in vitro device regulatory landscape and liaising with our network of experts, we’ll make sure you are well-prepared.
