Training

__________

Training

Bring your team up to speed with the latest EU requirements. Training is vital to ensure that your team has the knowledge required to meet your obligations for placing medical devices on the EU market.

Specculo provides a range of online or onsite training courses related to the obligations of economic operators with respect to the EU Medical Device Regulation 2017/745 (MDR) and EU IVD Regulation 2017/746 (IVDR). Our most popular courses are:

  • Post-Market Surveillance Activities and Post-Market Clinical Follow-up.
  • Obligations of Importers and Distributors (Articles 13 & 14).
  • Person Responsible for Regulatory Compliance (PRRC) (Article 15).
  • Directive-Regulation Transition.

As we are based in Malta, we provide local manufacturers, importers, and distributors training on their local obligations, such as Medical Device Registered Person (MDRP).

We also provide bespoke training, made-to-measure for your specifications. Pick a subject, set your requirements, and we will build a training session around these to provide you with the necessary knowledge to kickstart your transition to the EU Regulations.

Why Specculo

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

What You Get

Our training sessions will upskill your workforce in the areas you need the most.

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.