Clinical Services

MedTech CRO & clinical evalutations

We know the language of medtech companies. ISS AG takes into account the customer’s strategic objectives as well as any operational, ethical, regulatory and statistical requirements. ISS services begin with a first strategic design and extends to the final clinical investigation report. Our service attitude includes high quality, flexibility, cost effectiveness and speed. Clinical investigations include feasibility or pilot investigations, confirmatory clinical investigations for CE certification or post market investigations. We also offer legal representation of foreign sponsors in Switzerland and Europe.

Factsheets

Clinical Services

Clinical Investigations run by ISS AG are taking into account the strategic objectives of our customers as well as operational, ethical, regulatory and statistical requirements. We offer a value for our customers from a first draft design to the final clinical investigation report. Clinical Investigations include Feasibility or Pilot Investigations, Confirmatory Clinical Investigations for CE certification or Post Market Investigations.

Factsheet

Post Market Clinical Follow-Up Studies (PMCF)

Under the new Medical Device Regulation (MDR) and new Guidelines more often own PMCF-studies to confirm the safety and effectiveness of a medical device are requested by Notified Bodies. The ISS AG is an audited Clinical Research Organization (CRO), which has successfully carried out PMCF-studies.

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Clinical Evaluations according to MEDDEV 2.7/1 Rev. 4

Through our support you win time and assurance in your clinical evaluations. In addition, our process for the creation of a clinical evaluation offers you several options when defining the scope of work.

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Medical Writing

Medical Writing is gaining more and more importance for the medical device industry. Combining engineering with medico-scientific knowledge is key for creation of meaningful submission documents and publications Integrated Scientific Services (ISS AG) has decades of cumulative technical and scientific experience in providing supportive services to companies. ISS can help drive the writing of scientific documents in a highly efficient manner to maintain deadlines and budget constraints.

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Contact

Michel Weber

PhD in Life Sciences

Division Leader Clinical Services