Services Medical Devices Development
Regulatory expertise provided at the right stage is crucial to achieving compliance and successful market access. DLRC consultants have significant experience and are well placed to navigate regulatory hurdles having worked in industry, for Competent Authorities and Notified Bodies. Our consultants worked with clients to support device development, input on pre-market strategies and compile submissions.
Services include:
From concept to product realisation DLRC have the expertise to guide you through the process ensuring compliance with all Regulatory requirements.
Design and development process development will be different for every organisation and depend on the organisational structure and the type of device. DLRC is able to build a Design process to suit the organisation while remaining compliant with the regulations, adding value to the organisation.
Device testing strategy will be dependent upon the applicable standards relative to the device as well as the specific design inputs and verification requirements of the device. DLRC are able to create device specific testing strategy plans in order to optimise the design verification process and ensure the design requirements are effectively achieved.
Early regulatory interactions can be key in the first stages of developing a product particularly those where new innovations bring new regulatory challenges. Regulators globally have a mission to support innovative medical devices and have a variety of pathways to discuss important aspects of innovation right from the start. DLRC helps our clients to navigate these pathways globally to optimise the chances of future regulatory success.
Early access to scientific advice is currently determined by EU Member States Competent Authorities. DLRC can assist with facilitating interactions with Competent Authorities to help inform early stages of development. Under the new MDR and IVDR, the EC Commission has been tasked to set up Expert Panels, not as yet established, which are intended to provide input to key stakeholders.
The FDA offers the Breakthrough Devices Program for devices and technology intended for life-threatening or irreversible conditions and the Safer Technologies Program (SteP) for non-threatening or reasonably reversible conditions. These programs are beneficial in providing early collaboration with the FDA to expedite device development, assessment and review. DLRC can assist with determining eligibility and facilitating engagement with the FDA for such programs.
The MHRA Innovation Office supports the development of devices and manufacturing processes and provides free, confidential expert regulatory advice and guidance to organisations of all backgrounds and sizes based nationally or internationally. DLRC has experience of successful Innovation Office Interactions that have helped guide our clients in the early stages of developing innovative products.
