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Factsheets Regulatory Affairs

Plan B @ EAR: Safe EC-REP Solution for SWISS SMEs

Swiss manufacturers must prepare for the scenario of having to appoint an EU representative or European Authorised Representative (EAR) in the future. We have put together a package of services that increases the security for SMEs without their own subsidiary in the EU area to maintain the ability to deliver to the EU area and helps to minimize the financial and contractual risks.

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.

RA-Intelligence - Relieves Your Organization

ISS maintains a very well developed knowledge management. This makes it possible to create RA Intelligence tailored to your company and to make your RA processes and ultimately your company more efficient and cost-effective. The various elements ensure that you have a better grip on RA issues and that your staff is adequately trained.

Factsheets Clinical Services

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)

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

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.

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.

Factsheets Qualitymanagement & Engineering Support

Qualitymanagement Services

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.

Engineering Support

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.

Factsheet Software-Development


SW development for medtech according to the sets of standards of ISO 13485, ISO 62304 and FDA.

ARM Bootloader

Medical Grade Bootloader for ARM Microcontroller

Factsheet REGULA™

REGULA™ „Simplify your Regulatories“

Data-base driven application for efficient management and reporting of regulatory affairs activities.

REGULA™ Broschure

The Regulatoy Affairs Software for Medtech and IVD companies.