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Consultancy for Medical Devices

consulenza dispositivi medici - White Lab

White Lab's regulatory consultancy and support services for the Medical Device industry support customers to demonstrate the compliance and safety of active and non-active medical devices for CE marking and other international certifications.

White Lab's highly-trained staff provides technical-scientific assistance to establish the most appropriate testing services depending on the type of Medical Device and the customer's goals. We also provide support in the resolution of non-compliance to get devices onto the market as quickly as possible.

White Lab Laboratories know that customers have increasingly complex needs and that it is therefore necessary to have high-quality data certifying that the Medical and Pharmaceutical Devices are in full compliance with current regulations.

For this reason, we offer not only a comprehensive range of laboratory testing but also services ranging from consultancy to regulatory support, in order to support the customer from the design of the Medical Device up to its marketing and for its whole lifetime.

Firstly, the Risk Analysis management and the drafting of related procedures are carried out in line with ISO 14971 standard. This standard aims at ensuring the safety of a Medical Device throughout its whole life cycle, and its application is carried out in line with the quality management requirements of ISO 13485 standard, recognised as a 'harmonised standard' for Directives regarding Medical Devices (Medical Devices Directive 93/42/EEC, In-Vitro Diagnostic Medical Devices 98/79/EC and Active Implantable Medical Device 90/385/EEC).

To ensure the marketing of safe and effective products, it is furthermore compulsory to draft technical documentation including all the measures adopted by the manufacturer to meet the general safety and performance requirements set out in EU Regulations Nos 2017/745 and 2017/746. This constantly-updated collection of documents must in some cases be evaluated by a Notified Body to obtain and maintain the CE marking, which is an indispensable requirement for marketing the product in the EU.

The toxicological profile of the Medical Device is an essential element of the technical documentation. It must be drawn up to evaluate the interaction between chemical compounds and biological systems to identify possible adverse effects.

White Lab supports the customer also in the evaluation and interpretation of obtained results with reference to the indications for use of the product.

White Lab laboratories are ACCREDIA accredited and CBTL (Certification Body Testing Laboratory) certified for the national certification body BSI (British Standards Institution), and can ensure that your device is accepted internationally thanks to the CB test report and the CB certification scheme.

Thanks to its multidisciplinary approach, White Lab's offer includes
  • Technical-scientific support to decide and develop the most adequate testing process for your Medical Device
  • Biological Evaluation Plan (BEP) in line with ISO 10993-1:2018
  • Gap analysis
  • Interpretation of biological evaluation and overall biological risk assessment data Biological Evaluation Results (BER)
  • Toxicological evaluation of the results of chemical characterisation to evaluate the interaction between chemicals and biological systems in order to identify possible adverse effects
  • Risk analysis carried out in line with ISO 14971 standard, regarding all the stages of the product life cycle to evaluate the compliance with the requirements for medical devices and active implantable medical devices (EU 2017/745 and EU 2017/746)
  • Assistance and consultancy to obtain certifications: CE marking (EU Regulations 2017/745 and 2017/746), Registration for US FDA, Korean FDA, Chinese FDA, and more Notified Bodies outside the EU
  • Assistance in drafting technical documentation
  • Assistance in drafting the Use and Maintenance Manual
  • Assistance with responding to deficiencies identified during the evaluation carried out by EU and non-EU Notified Bodies
  • Consultancy for drawing up and managing the Quality Manual and the Operational Management Procedures
  • Assistance with solving any problem that may arise during the design phase
  • Post-market surveillance assistance
  • Assistance with preparing for inspections
  • Audits to verify the conformity of the system
  • Assistance with Supplier Qualification
  • Managing relations with the Certifying Body (Notified Body)
  • Service of Informative update on industry laws, regulations, and Pharmacopoeias for the sector.
  • Tailor-made training on the management system and technical and regulatory aspects
  • Annual consultancy service for the ISO 13485 quality management system

Would you like to receive more information or schedule a customised consultation for your company? Please, fill out the form and we will get back to you as soon as possible.

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