Quality and regulatory compliance consulting worldwide
At MD Compliance, we specialize in medical device quality and regulatory compliance consulting. Based in Glasgow but working with clients in the UK, EU and North America, we help manufacturers achieve full compliance with quality system, regulatory and clinical requirements, with a comprehensive service designed to meet the needs of each individual client. Read below to find out more or call us today on +44 (0)7973 403 486 .
Quality Systems
We specialize in Quality Management System (QMS) implementation, development, procedure/process improvement, auditing and coaching, alongside a comprehensive QMS support service.
We are highly experienced in supporting your partners/suppliers by providing targeted process supplier audits to ensure key external parties are living up to their agreed obligations.
We have years of experience auditing to ISO 13485:2016, the EU Medical Devices and In Vitro Diagnostic Devices Regulations, FDA QSR/QMSR, Canadian MDR and other international quality and regulatory requirements including those covered by MDSAP. We can also offer qualified auditing against ISO 9001:2015.
If you need to set up a new quality system, update a system that has become out of date, see a need to have a thorough independent audit/gap assessment or improve an existing system, don't hesitate to get in touch with MD Compliance.
Training
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.
We offer training ranging from basic awareness of quality systems and regulatory requirements, to specific topics such as FDA inspection preparation, internal auditing, risk management and other topics.
Get in touch with us to find out more about the range of
training we provide.
Regulatory Affairs
We understand that you want to get your products approved and sold in as many markets as possible, and as quickly as possible! But the variation in regulatory requirements from country to country can be confusing, to say the least.
We offer consulting for international regulatory affairs, to give you the best chance of achieving compliance in the world's largest healthcare markets.
Our knowledge and experience with the regulatory authorities in key jurisdictions mean you'll be in an excellent position to gain the relevant approval for your products.
Clinical Evidence
Changes in the healthcare sector mean that medical
device manufacturers are now required to show robust clinical evidence that support the performance of their products. Regardless of the classification of your medical device(s), 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 regulation and ensure your products can remain on the market.
This includes developing your Clinical Evaluation Plans and Reports which must be generated at particular intervals to comply with regulations in most
major markets.
