Medical device consultancy

Medical devices

Our medical device consultancy covers all types of medical devices.

According to Regulation 745/2017 and Regulation 746/2017, a medical device must have a medical purpose (with the exception of the eight categories listed in Annex XVI, which have an aesthetic purpose but are treated as medical devices). Any equipment, reagent, software, etc. used to diagnose, alleviate or compensate for a disease. This also includes products used to disinfect other medical devices or condoms. Containers intended exclusively for human samples (biopsies) are also medical devices.

Any medical device must comply with regulatory requirements in accordance with the classification of medical devices.

The European Union has guidelines to distinguish between medicinal products (which are absorbed by the body) and medical devices (which have a physical effect, such as wound dressing).

Medical device consultancy

Our medical device consultancy services for the healthcare and cosmetics industries provide comprehensive support throughout the entire lifecycle of each product, offering strategic, technical, legal, documentation and management support. They focus on:

  • CE marking for medical devices. CE marking is a requirement for accessing the European market. We assist with the CE marking process for your medical device, regardless of its class.
  • Approval of a medical device. We guarantee successful approval as quickly as possible.
  • Technical and legal support. Comprehensive regulatory services covering both national and international markets. With our service, we ensure regulatory compliance, in line with the requirements of each market and tailored to the needs of each product. 
  • ISO 13485 certification for medical devices. ISO consultancy to obtain ISO 13485 certification for medical devices through a reputable certification body. We assist you with internal ISO 13485 audits or those of your suppliers.
  • ISO outsourcing. We help you maintain your ISO certificate. We know how to integrate medical device requirements into your integrated ISO 13485 management system for medical devices and your ISO 9001 quality management certificate.

Strategic management systems consultancy with over 20 years of success.