With our experience in Europe, North and South America, Asia and the Middle East we can help you to a rapid market approval in all regions. Whether for short or long term contracts – we can manage your product registrations for all target markets, supported by our in-house software REGULA™. We offer long-term experience in writing clinical evaluation reports.
Worldwide Registrations RA Training RA Intelligence
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.
CRO, Clinical Studies & PMCF Clinical Evaluations acording to MEDDEV 2.7/1 Rev 4Through our focus on medical engineering you gain a competent partner for your software development. As we do not just write software but develop under consideration of the regulatory requirements and the relevant standards you will receive an adequate SW product which complies with the regulatory requests. You can also outsource subprojects or validations to us. If you have a shortage in your resources, we support you in the timely completion of your product.
IEC 62304 Software Project Management SW Verification & SW Validation
With its service ISS is always very close to the operating policies. ISS understands the daily challenges to connect with quality management systems and regulatory requirements and therefore can support you actively and towards product entry and implication. Our quality management services are oriented in accordance to regulatory guidelines (e.g. 93/42/EWG, 98/79/EG, 21CFR820).
ISO 13485 Audit & Engineering Support