ISS AG
Robert-Walser-Platz 7
CH-2503 Biel
Switzerland
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.

RA Intelligence - Relieves Your Organization

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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.


Clinical Services

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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) pdf icon 16px
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 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

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Well written, standards-compliant documents for the medical device industry.


Services Quality Management MedTech

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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

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

Industrialisation

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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.

Software Development

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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.