Support Regulatory Affairs
Each market still requests its specific requirements for registrations of a medical device. Our experience in Europe, North- and South America, Asia as well as the Middle East enables us to support you in an efficient obtaining of the aspired market release.
Factsheet 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.
Post Market Clinical Follow-up Studies (PMCF)
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.
Clinical Evaluations according to MEDDEV 2.7/1 Rev. 4
Factsheet Clinical Evaluation 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.
Factsheet Medical Writing
Well written, standards-compliant documents for the medical device industry.
Services Quality Management MedTech
Set-up and maintenance of a quality management system according to ISO 13485 / QSR is an indispensable condition to be active in the medtech sector. We support you in all important steps of a (re-)registration or adjustments of your QMS to new requirements and offer comprehensive consulting services.
Qualification and Validation according to ISO 13485 and cGMP
Medical Technology: Qualification and Validation according to ISO 13485 and cGMP – Protocol development, DQ, IQ OQ PQ, statistical methods and tools, Reports
With our experience and knowledge we help you to create and validate your processes according to the regulations by ISO and GMP and to additionally reduce time and costs.
SW development for medtech according to the sets of standards of ISO 13485, ISO 62304 and FDA