Services

At ABC we aim to deliver not only the basics above, but also a more complete service to achieve wider targets. We have the ability to bring together a range of complementary services to offer you combinations such as regulatory and marketing strategy reports, or clinical studies with product design. We can also offer you product support/representation in the USA and Australia.

Services include:

• Project Management
• Medical Device and IVD Regulatory Affairs design dossiers
• CE Marking and Technical File reviews
• Clinical Evidence & Post Market Surveillance (PMS)
• Clinical Evaluation Reports (CER)
• Clinical Strategy & Protocols
• Marketing Support in Europe and North America (new)
• Business Assessment and Due Diligence (Acquisitions)
• Supplier Auditing
• Internal Auditing
• Product Marketing and Development Projects

To find out more about specific services, click on the links below

> Project Management
> Regulatory Affairs
> Clinical Evidence
> Business Assessment
> Product Marketing
> Quality Assurance
​> European Authorised Representative Services

ABC are in partnership with Cognidox.  Some med tech eQMS options are clunky and prescriptive in the way they operate.  Cognidox is adaptable, scalable, and designed to flex with your needs.

​​We are also an authorised consultant for BSI