Regulatory Affairs Consultant
Regulatory Affairs - Medical Devices
Cranage Veritas are a regulatory affairs consultant for medical device and medical electrical equipment manufacturers, helping them in achieving global market access.
We work closely with designers, developers, and manufacturers to guide you through the entire medical device regulatory journey - from concept design to post-market surveillance.
With expertise in the IEC 60601-1 series of standards and Medical Device Regulation (EU 2017/745) requirements, our team delivers tailored solutions that ensure compliance, streamline approvals, and facilitate entry into your target markets.
Our Core Services
- Crafting tailored regulatory strategies for product design and development against the required directives and standards, product evaluation and government registration. This includes early guidance on regulatory pathways for specified global markets.
- Desktop reviews of the product designs throughout their lifecycle, in line with the requirements of IEC 60601-1.
- Compiling, reviewing, and submitting comprehensive regulatory applications (e.g. MHRA, 510(k), CE Mark submissions) to local and international authorities.
- Supporting post-market surveillance, product modifications, certification renewals, and ongoing compliance activities to adapt to product and regulatory changes.
- Assisting in the design, implementation, and maintenance of QMS in line with ISO 13485.
- Offering bespoke training to enhance regulatory knowledge for individuals or groups.
- Advising on international regulatory requirements (FDA, MHRA, etc.) to facilitate entry into new markets.
Vastly Experienced
Our Consultants at Cranage Veritas have years of hands-on experience navigating the complex regulatory frameworks for a variety of medical devices across global markets. They are also qualified product certifiers to IEC 60601-1, which brings invaluable experience to the table when designing new medical products, and can offer guidance on product design and the requirements of risk management files.
We offer services tailored to each client's unique requirements, ranging from simple guidance and strategic regulatory planning to being fully integrated within the design and certification process - the choice is yours.
