What we do

MEDICAL DEVICES
Quality engineering​

Quality engineering

  • Design Control
  • Risk Management
  • Design Validation and Usability
  • Biocompatibility Evaluation
Read more
Regulatory affairs​

Regulatory affairs

  • MDR Compliance
  • International regulatory consultancy
  • US Market: FDA Registration, Establishment Registration, Annual listing
  • Vigilance System
  • Market Access
  • Health Advertising and free sale certificates
Read more
Quality compliance​

Quality compliance

  • Quality system certification
  • Post-Market Surveillance (PMS)
Read more
SERVICES
SW and active medical devices

SW and active
medical devices

ART. 117 Combination products

ART. 117
Combination products

In-vitro
diagnostics

Training

Training

Prrc​​

Prrc​

Process validation​

Testing activities​

Testing activities

Clinical data management

Clinical data management

Other custom products

SW and active medical devices

SW and active
medical devices

Medical Device software and electromedical equipment represents an ever-increasing segment of the business for medical companies. VLF Consulting offers a team of specific experts in this sector to support during Design Control, Risk Management, Validation activities and for all preparatory activities for CE marking and placing on international markets.
ART. 117 Combination products

ART. 117
Combination products

The new Medical Devices Regulation has introduced the need for some Combination Products to request a Notified Body Opinion, which requires the creation of Technical Documentation relating to the part of the product considered a Medical Device, very similar to the documentation required for a stand-alone medical device . VLF Consulting supports companies in undertaking this process with the chosen Notified Body and in preparing the Technical Documentation to be submitted.

In-vitro
diagnostics

In vitro diagnostics (IVD) is an essential part of healthcare. It has been estimated that the results of in vitro diagnostic tests influence up to 70% of clinical decisions, despite representing only 0.8% of total healthcare costs. The legislation that regulates the CE marking and the placing on the market of IVD Devices in the European Union is currently EU Regulation 2017/746, which, starting from 26 May 2022, has repealed and replaced Directive 98/79/EC implemented in Italy through D.L. n. 332/2000 and establishes the requirements that IVD manufacturers must comply with to produce and market IVDs in the European Union. For IVD Devices deemed to pose a greater risk to the patient or to public health, an independent third-party body (Notified Body) must evaluate these devices, certifying their compliance with regulatory requirements through the issuing of CE Certification. VLF Consulting is at your side in verifying compliance with EU Regulation 2017/746 of the documentation produced and in discussions with the Notified Body.
Training

Training

VLF Consulting offers the possibility of in-house training sessions on specific topics of interest to Clients, and is available for on-the-job training on all the activities proposed among its services.
Prrc​​

PRRC

According to the MDR 2017/745 and IVDR 2017/746 regulations, micro and small businesses can delegate the functions and responsibilities of the person responsible for compliance with the regulations to a third party. VLF Consulting assists medical companies in fulfilling the role of person responsible for compliance with the legislation.
EC Rep for ExtraEU companies
 VLF Consulting directly exerts agent functions within the European Union as required by the relevant regulations.

Process validation​

New regulations and industry standards require greater attention to the validation of processes such as production, sterilization, cleaning, washing, clean room, packaging and many others. Vlf consulting is a reliable partner for the coordination of the activities carried out internally by the manufacturer, or to directly manage these activities and generate the necessary documentation to support the validation of the related processes.
Testing activities​

Testing activities

The Medical Devices market increasingly requires that functional and safety verification activities take place in suitable laboratories. VLF Consulting has contacts with qualified laboratories for carrying out tests on medical devices (biocompatibility, static/multicyclic functional tests, microbiological, transport, stability, …)
Clinical data management

Clinical data management

Clinical Evaluation
 VLF Consulting assists medical companies in the evaluation strategy, implementation and management of activities related to clinical evaluation, such as bibliographic research and collection of other information from the market, and in the drafting of the relevant documentation (CEP and CER)
Post-market Activities
 VLF Consulting assists medical companies in the creation and updating of a Clinical Follow-Up plan, also providing assistance for the management of Clinical Evaluation update activities (PMCF Report), such as bibliographic searches, database consultation, processing and collection of feedback from the market.
Biostatistics
VLF Consulting assists investigators in the design of their research projects, analyzing biomedical data and dealing with their reporting to regulatory bodies and scientific journals, also organizing training courses relating to medical research methodologies

Other custom products

Please contact us for projects about: implementation of the ISO 9001 Quality Management System, cosmetics, biocides, food supplements, feed.

Call us for an appointment

+39 045 7114348

Feel free to contact us

info@vlfconsulting.eu

Reach to us via our location

View Map