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 70 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 established since 2015.
About
MD Compliance was founded in Glasgow, Scotland in 2015 and has grown steadily to the point where we are serving approximately 25 active clients at any one time. It is our aim to be the full-service who will provide you with personalized and targeted advice and value-added consulting input.
It is our aim to be the full-service medical device Quality Management System (QMS) and Regulatory Affairs consulting service of choice for your start-up or SME. While we thrive on helping small teams learn how to meet all relevant quality and regulatory requirements, we also offer a very cost-effective option to larger companies 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 and improvement, gap assessments, QMS upgrades to meet additional requirements, supplier audits, as well as Post Market Surveillance, Clinical Evaluation and Risk Management.
