Medical Device and Regulatory Services
SGB QA/RA Consulting was launched in 2017 to provide a complete range of services to meet the QA/RA compliance needs of medical device companies.
We have over 30 years’ experience working with a range of medical device clients from start-ups to global multi-nationals on a wide range of projects including:
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Audit Remediation
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Market Access: 510k Submissions / MDSAP / ASEAN / Canada / Australia
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Brexit Preparation - EU Authorised Representative / UK Responsible Person
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UDI (Unique Device Identification)
Our Services
We provide a range of offerings covering all aspects of Medical Device and Regulatory Services
We have experience of working with all classes of medical device (Class I, IIa, IIb and III) across a wide range of product types
We will help you ensure your medical devices remain compliant and able to be sold in the EU
We are a leading supplier of Software Quality Assurance and Regulatory Advice to industry and academia with many years’ experience
We have worked with many clients to assist them in gaining market access to global markets
Whether based in the UK or overseas we will ensure your business maintains access to key markets following Brexit.
We also offer a range of additional services. Click below to find out more
Testimonials
‘Sam provided training in some keys areas for myself and colleagues. He was professional , very helpful and we all came away with a greater understanding. We picked up some memorable hints and tips going forward to assist in an even clearer and concise way of working. He answered all our questions in detail. Would highly recommend.’
Caterina Buono
Quality Assurance and Regulatory Affairs Specialist
Ready to find out more?
We have over 25 years’ experience working with a range of medical device clients from start-ups to global multi-nationals on a wide range of projects. Please do get in touch to organise an initial phone or video call to discuss your specific project requirements.