Robert-Walser-Platz 7
CH-2503 Biel
Tel. +41 32 513 67 67
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Support Regulatory Affairs

Factsheet Regulatories pdf icon 16px
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.

Qualification and Validation according to ISO 13485 and cGMP

Factsheet Qualification Validation pdf icon 16px
Medical Technology: Qualification and Validation according to ISO 13485 and cGMP – Protocol development, DQ, IQ OQ PQ, statistical methods and tools, Reports

Clinical Services

Factsheet Clinical Services pdf icon 16px
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.

Services Quality Management MedTech

Factsheet Q-Support pdf icon 16px
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.


Factsheet Industrialisation pdf icon 16px
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.

Clinical Evaluations according to MEDDEV 2.7/1 Rev. 4

Factsheet Clinical Evaluation according to MEDDEV 2.7/1 Rev. 4 pdf icon 16px
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

Factsheet Medical Writing pdf icon 16px
Well written, standards-compliant documents for the medical device industry.

Software Development

Factsheet SW Development pdf icon 16px
SW development for medtech according to the sets of standards of ISO 13485, ISO 62304 and FDA

REGULA „Simplify your Regulatories“

Factsheet REGULA™ pdf icon 16px / REGULA™ Brochure pdf icon 16px DeviceMed Article REGULA™ pdf icon 16px (German)
Data-base driven application for efficient management and reporting of regulatory affairs activities.