General Consulting

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General Consulting

The EU Regulations can be a hard nut to crack. We have the expertise and tools you need to help you succeed in the EU market. Initially, we can set up a call to discuss any issues you may be encountering and provide you with a proposal of how you can get ahead of the game in the EU. 

We can provide you with expertise in all areas of the EU MDR/IVDR, including:

  • Obligations of Economic Operators (Manufacturers, EU Authorised Reps, Importers and Distributors).
  • Person Responsible for Regulatory Compliance (PRRC) (Article 15).
  • Conformity Assessment Procedures.
  • Article 22 Systems and Procedure Packs.
  • Article 120 / Article 110 Transitional Provisions.
  • Unique Device Identification (UDI).
  • Device Classifications.
  • Labelling and IFU Requirements.
  • Risk Management.
  • Post-Market Surveillance and Vigilance.
  • Clinical Evaluation.
  • Biological Evaluation.

and much more.

What you get with Specculo

We have years of experience in handling large and small projects alike on a vast range of medical devices and IVD technology.

Experience

As your regulatory consultant, you get our full attention throughout the project.

Expertise

You can expect high quality, state of the art technical documentation.​

Fast lead times

We give you our time and take you through the created documentation, and how to maintain it.​

Simplify your compliance workflow.