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In order to have the indications of your medical device certified by the notified body, the evidence must be presented with a solid methodology, integrating the data present in the literature on equivalent medical devices with any clinical data collected on your medical device.

The methodology is precisely described both in MEDDEV 2.7 / 1 and in the Medical Devices Regulation (EU) 2017/745. The D&V farma scientific team members either direct or belong to laboratories characterized by a high quality scientific production, a requirement that allows them to master the data analysis methodology necessary for certification.

Primum non nocere is the cornerstone on which both the medicine and the legislation on medical devices are based. Starting from the medical device design, the ISO 10993/1 indicates how to collect the safety data present in literature and, if necessary, which laboratory tests to perform and how.

The collection of safety data present in the literature is integrated within the Italian and European regulatory framework that increasingly takes into account animal welfare. Toxicology and pharmacology opinion leaders are key members of D&V farma scientific team.

Keep calm and answer back. Faced with harmonized legislation at European level, the competent authorities of each state have the right to request additional documentation to support the efficacy, safety or even the correct regulatory classification (i.e., medical device or drug). The drafting of an expert report with solid scientific foundations countersigned by university professors with consolidated experience is essential to guarantee the marketing of the DM.

Let your product stand out. Both the surveillance activities (post marketing clinical follow-up) and the promotion of the product require a collection of clinical data.

D&V farma provides support in identifying and interacting with Opinion leaders, in the drafting of protocols and in data analysis.

To obtain the maximum yield from the clinical data of your product in terms of professional and scientific audience, we offer a 360 ° assistance: statistical analysis of the data, choice of the target journal, drafting of the scientific article, submission, response to reviewers' comments and proofreading.

I nostri medical writer non sono semplici free-lance ma sono ricercatori universitari che di routine generano dati scientifici e scrivono articoli scientifici.

Make your opinions 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 to assert their point of view in cross-examination with the judge’s expert.

It is the first recognition that our customers give us. For this reason, in addition to entrusting us with their projects, our customers recognize us as an integral part of their team and interface with us even for simple advice. Test us!

D&V Farma has meticulously built a network of experts and an operating model with the capability to rapidly provide the client with effective solutions.

We put the maximum effort into every project by offering solutions that are a real added value for our customers, going beyond the mere execution of the assigned task.