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 greenlight.guru, offering Medical Device Companies
exclusive ​Quality Management Software to help you get to market faster.

​​We are also an authorised consultant for BSI