Medical Device Quality and Regulatory Consulting
MD Compliance offers quality assurance, regulatory and clinical evaluation consulting for manufacturers of medical devices. We specialize in providing implementation and support for Quality Management Systems and helping manufacturers achieve total compliance with quality system and regulatory requirements in the EU, UK, USA, Canada and other key markets.
Book an initial consultation today!
+44 (0)7973 403 486
fast response times
due diligence
flexibility
over 100 years of combined experience
We specialize in Quality Management System (QMS) implementation, development, procedure/process improvement, auditing and coaching, alongside a comprehensive QMS support service.
We offer consulting on international regulatory affairs, to give you the best chance of achieving compliance for your device in many of the world's key healthcare markets.
Our training courses can help your staff learn to work within existing regulations and quality assurance requirements, potentially saving time and money on each project by enabling your team to approach a project from a regulatory and QA perspective.
MD Compliance, along with our carefully selected partners, can help you source and collate all the data that will be required to comply with clinical evidence requirements and ensure your products can remain on the market.
Mission
At MD Compliance, our mission is to empower innovative medical device manufacturers – and related parties – with personalized and expert quality and regulatory consulting. We are committed to helping you navigate the regulatory landscape in major global markets swiftly and efficiently, ensuring compliance and fostering the rapid development of cutting-edge healthcare solutions. Through our agile approach, we aim to be the trusted partner for startups and SMEs, providing streamlined solutions that accelerate market entry, drive innovation, and ultimately enhance patient outcomes.
Vision
We believe in building long-term relationships with our clients, partners, employees, and community. The growth and success of our business is rooted in these relationships and deep customer loyalty we have worked hard to establish since 2015.
About
MD Compliance was founded in Glasgow, Scotland in 2015. We have grown each year since then, having successfully completed approximately 150 projects for just over 80 customers located in the UK, EU, U.S. and Canada. Our team includes highly experienced Quality and Regulatory professionals and we enjoy access to a wide and varied network of subject matter experts located in various parts of the world. Together we are well positioned to answer your questions and get to work solving your simple and complex compliance needs!
It is our aim to be your full-service consulting team of choice, and we will work hard to maintain your confidence. While we thrive on helping smaller, growing organizations learn how to interpret and meet all relevant quality and regulatory requirements, we also offer a very cost-effective option to larger manufacturers who may be looking to supplement their existing internal resources and knowledge by providing qualified and experienced external expertise in areas such as Technical Documentation updates, QMS creation / implementation / auditing / improvement, gap assessments, supplier audits, as well as Post Market Surveillance, Clinical Evaluation and Risk Management. Go to our Services page to see how we can start helping you today!
