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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 in the process to obtain the CE marking by means of a Risk Analysis and the drafting of BEP, BER, Gap Analysis, Toxicological Evaluation, and technical files.

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.

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 a Technical File 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 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 following products are excluded from this evaluation:

  • Class I Medical Devices
  • Tailor-made Medical Devices
  • Some categories of in-vitro medical-diagnostic Devices (IVD)

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

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

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 standard
  • Gap analysis
  • Interpretation of data from biological evaluation and overall biological risk assessment: 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 (93/42/EEC, 90/385/EEC, 98/79/EC and following amendments)
  • 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 with drawing up technical files
  • 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
  • Assistance with Supplier Qualification
  • Managing relations with the Certifying Body (Notified Body)
  • Service of Informative update on laws, regulations, and Pharmacopoeias for the sector

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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