The first stone of One Health Compliance has been laid in 2017. While beginning a new chapter with reinforced services highlighted by a new visual identity (please refer to our “amazing” first news), you will find hereafter a summary of the key facts of those first 3 years…
Mapping of the missions carried out
The main activities carried out concerned:
- Training on vigilance, EU MDR 2017/745, technical documentation (CE marking), requirements for medical devices utilizing materials of animal origin (including ISO 22442 requirements);
- Quality management with support for implementation of quality management systems, audits and preparation for audits according to ISO 13485 requirements;
- Regulatory and clinical strategies for the EU market (requirements CE marking), the US markets (FDA requirements) and for the veterinary market;
- Producing technical files, clinical evaluation files and response files to questions from notified bodies.
The projects mainly concerned the field of human health. However, we are working to strengthen communication around the veterinary sector to participate in highlighting its huge interest.
Our green touch
We used in more than 95% of the time trains, public transport or we walked (but we avoided singing in the rain while doing it) to meet our customers and our (future) partners.
We are committed to working on our digital pollution (including regular cleaning of our mailbox and the storage of what is only necessary) as well as on reducing waste during our travels (especially related to meals).
Meetings and partnerships
We had the opportunity to participate in a workshop on animal health and to conduct a session on medical devices during the European dermocosmetology days.
These 3 last years have also enabled us to strengthen the network of One Health Compliance. We are thus strengthening links with companies that have the same collaborative spirit, human values and who have understood the value of taking regulatory requirements into account upstream (without forgetting fundamental criteria: good sense of humour and enjoy to eat good food).
Our first partners are working in the field of human factors, veterinary intelligence and information security management.
Do not hesitate to follow us on LinkedIn, we will have the opportunity to illustrate our approach through practical cases!
October 6, 2020