To certify your medical device claims, it is essential to provide solid evidence by combining your own clinical data with literature on equivalent products.

D&V Farma applies the methodology defined by MEDDEV 2.7/1 and Regulation (EU) 2017/745, with a team operating in high-output scientific laboratories and fully skilled in the data analysis required for certification.

Preclinical studies are essential to validate the initial hypothesis and define the direction of development.

D&V Farma designs and coordinates in vitro and in vivo studies, applying robust and customized protocols to gather reliable evidence that supports future certification.

Primum non nocere — “First, do no harm” — is the principle at the foundation of both medicine and medical device regulations.
ISO 10993-1 guides safety assessment from the very design phase, starting from literature data and resorting to testing only when necessary.
D&V Farma operates in full compliance with animal welfare regulations, with a team that includes recognized experts in toxicology and pharmacology.

A deep understanding of your medical device means continuously monitoring its safety and performance. Both Directive 93/42 and the MDR Regulation assign a central role to vigilance and post-market surveillance.
D&V Farma supports manufacturers in managing these processes, preparing accurate and structured reports to ensure proactive and compliant data collection.

Keep calm and answer back.
Even with harmonized regulations, national authorities may request additional documentation regarding the safety, efficacy, or classification of a medical device.
D&V Farma prepares scientifically grounded expert reports, signed by university professors, to ensure the proper market placement of your medical device.

Let your product stand out. Both post-marketing clinical follow-up (PMCF) activities and product promotion require the collection of clinical data.
D&V Farma provides support in identifying and engaging opinion leaders, drafting protocols, and performing data analysis.

We enhance your product’s clinical data by turning it into impactful scientific publications.
We offer complete support — from statistical analysis and journal selection to manuscript writing, submission, and review management.
Our team of medical writers consists of university researchers with hands-on experience in producing scientific studies and publications.

Make your voice heard. In civil proceedings, technical consultancy is the activity carried out by an expert with specific skills and knowledge.
We assist companies and law firms in asserting their position during discussions with court-appointed experts (CTU) or in arbitration proceedings.

Create added value. Protect what makes your medical device unique.
D&V Farma has over 10 years of experience in patent drafting and collaborates with law firms specialized in industrial property.
We support you through every stage — from drafting and data collection to support claims, to managing search reports and enforcement activities.