Your partner for CE marking of
Medical Devices

OUR MISSION

Passionate experts in MedTech for more than 20 years, we support Swiss and French SMEs and start-ups on the steep path of placing or keeping medical devices on the market.
We can be involved as a service provider, consultant or resource for R&D, quality, clinical or regulatory teams.

OUR SERVICES

Support in the
START-UP phase

• QMS - ISO 13485
• Technical documentation
• Risk analysis - ISO 14971
• Usability - IEC 62366
• Other services as required
.
.
.
More

Expert reports

• Biological Risk Assessments ISO 10993-1
• Clinical Evaluation Reports RDM / MEDDEV 2.7.1 rev 4
.
.
.
.
.
.
More

ISO 13485, MDR, MDSAP Compliance

• Internal Audits
• MDR / MDSAP Gap Analysis
• External audits preparation / follow-up
• Notified Body interactions
• Remediation of audit non-conformities
• Post-market clinical follow-up
• Post-market surveillance
.
More

WHO WE ARE

Jean-François Lataste

Jean-François has more than 25 years of experience in medical devices. Trained as an engineer, his expertise covers product development, clinical research and quality assurance. His therapeutic knowledge includes orthopedics, spine, neurology, cardiology, and others, for devices from class I to III.
Trained on technical and scientific excellence in large groups and with practical experience in start-ups, he has particular expertise in risk management, QMS implementation and audit, scientific literature review and post-market clinical follow-up (PMCF). Over the last few years, he has developed an original platform for multiple post-market clinical studies, providing significant contributions to Clinical Evaluation Reports (CERs) or reimbursement files.

Christian Pittet

Christian has more than 20 years of experience in medical devices. He holds a Master and PhD in materials science and a Master’s degree in biomedical engineering. His areas of expertise cover product development, clinical studies, quality assurance and regulatory affairs. He has acquired solid knowledge in therapeutic areas such as orthopedics, spine, bone reconstruction, endodontics and periodontics.
He has many years of experience in creating technical documentation for CE marking and is particularly skilled in writing Clinical Evaluation Reports (CERs) and Biological Risk Assessments (BRAs). His recent activity as Director of Quality and Regulatory Affairs in an SME has especially led him to study the new 2017/745/EU Regulation in order to complete the transition from MDD to MDR.

OUR VALUES

Relationship

We approach our missions in a spirit of listening and partnership. From our first touchpoint, you work with the experts who will carry out the mission. We work to create a quality relationship in which communication remains open and efficient.

Commitment

The expertise of each of us is mobilized on every single mission. Quality and thoroughness go hand in hand with flexibility and pragmatism to enable you to achieve your objectives. We want to offer you the best service for the right price.

Ethics

Three pillars feed our energy: our contribution to the regional development by working with local service providers and customers; our personal and associative commitments for an ecological, energetic and solidarity-based transition; our families.

CONTACT

Medalps SAS, 260 chemin de Poisan, 01220 Divonne-les-Bains, France – Société immatriculée au registre du commerce de Bourg-en-Bresse – SIREN 879687200