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The ISS Team has received reinforcement:

Weber Michel MWE small

Dr. Michel Weber

ISS AG decided to strengthen its competence in clinical operation services by building a separate organizational unit lead by Dr. Michel Weber joining the company. His experience as a former COO of international and Swiss Clinical Research and as Head of Clinical Research Operation at Novartis adds a lot of knowledge in all services around clinical trials. Dr. Michel Weber will also be a member of the executive board.


Item Sandra SIT small

Sandra Item

The ISS Team is getting reinforced by Sandra Item in the areas of regulatory affairs und knowledge management.




Event: New MedTech EU MDR/ IVDR Regulations - Consequences and Solutions (January 30th 2018)

Monday, 18 December 2017

The new Medtech EU MDR/IVD regulations published at the end of May pose a major strategic and operative challenge to the entire industry, and they will have a major impact...

ISS-Talk at the Tuttlinger Innovationsforum on October 19th

Wednesday, 02 August 2017

Digital Regulatories is a hot topic. The title of Hanjoerg's (CEO of ISS AG) speech at the Tuttlinger Innovationsforum will be “Digital RA, a contribution to a shorter time to...

3D Printing, impact of MDR

Sunday, 25 June 2017

ISS CEO Hansjörg Riedwyl is a speaker at the symposium “3D Printing for Life Sciences” in Muttenz on July 4th 2017. 3D Printing is one of the mega trends in...

Formation – Évaluation clinique selon MEDDEV 2.7/1, Révision 4

Thursday, 02 March 2017

ARIAQ et ISS AG proposent une formation d’une demi-journée pour les fabricants de dispositifs médicaux dont l’objectif est d’illustrer les exigences des évaluations cliniques selon « MEDDEV 2.7/1, Révision 4 » par des exemples concrets...

MDR event with participation of ISS

Thursday, 09 February 2017

At the first Swiss Medtech Conference on MDR, ISS will be involved with contributions around UDI and Eudamed. These two topics are on BVMed’s top 5 list on changes related...

Further clinical evaluation of ISS AG meets the requirements

Thursday, 26 January 2017

The process established by ISS AG for the preparation of clinical evaluations was again recognized by a positive assessment from a well-known Notified Body. "The clinical evaluation was established after...

ISS AG is now a member of the BVMA e.V.

Monday, 05 December 2016
ISS AG is now a member of the BVMA e.V.

ISS AG has been accepted as a member of the BVMA e.V. The Federal Association of Contract Research Organisations (BVMA) e.V. was founded in July 1991 to represent CROs (Contract Research Organisations)...

ISS AG has been successfully audited as clinical Contract Research Organisation (CRO)

Friday, 25 November 2016

The audit served to assess ISS’ adequacy and quality level in order to assure that the systems, procedures, practices and documentation at the CRO comply with Good Clinical Practice (ICH...

Regulatory Affairs Software – No more missed deadlines

Tuesday, 01 November 2016
Regulatory Affairs Software – No more missed deadlines

Read our article in the medical journal DeviceMed With our Regulatory Affairs Software REGULA™ daily RA activities can be greatly simplified. This increases efficiency and shortens the time to market,...

Successful application of MEDDEV 2.7/1 Rev. 4 for clinical evaluations

Monday, 24 October 2016

For several weeks now new, substantially stricter rules have been in place for clinical evaluations. All notified bodies known to us now require the application of Rev. 4 of the...

Successful maintenance audit for ISO 13485

Thursday, 26 May 2016

The ISO 13485 certification of the ISS AG was successfully maintained. The auditor issued a thoroughly good report and recommends maintaining the ISO 13485 certification without corrective actions requirements. This...

REGULA™ - New Release V.8.0 in Q2 2016

Tuesday, 15 March 2016

A facelift, performance optimization and much more functionality The launch of version 8.0 of our Regulatory Affairs Software REGULA™ is planned for Q2 2016. In addition to a new look...

Extension of the Supervisory Board

Thursday, 28 January 2016
Extension of the Supervisory Board

Der Verwaltungsrat der ISS AG, Integrated Scientific Services wurde verstärkt durch:   Jürg Ryffel war als Geschäftsführer, Bereichsleiter sowie Gesamtprojektleiter in verschiedenen Unternehmen der Branche Industrie/Medizintechnik tätig. Seine Erfahrungsschwerpunkte liegen in den...

Meet the Expert Implants Interlaken

Thursday, 25 June 2015

The abstract of SpineWelding and ISS AG is published. Our company, ISS AG, participated in the congress and was presenting together with SpineWelding AG an abstract on Clinical investigations with...

Surveillance Audit by Notified Body DQS

Wednesday, 24 June 2015

The QMS of ISS was recertified successfully by our Notified Body DQS. The main Focus of the audit was on the process of software development and the Clinical Research Organisation...

«i-net Medtech After-Work Regulatory Affairs Circle» with ISS AG

Wednesday, 20 May 2015

The «i-net Med­tech Af­ter-Work Re­gu­la­to­ry Af­fairs Cir­cle» is based on re­quests from par­ti­ci­pants of last year’s i-net RA Stra­te­gy work­shop. The in­ten­ti­on of the cir­cle is to meet up twice...

Another success for REGULA™

Friday, 20 February 2015

A multinational MedTec enterprise is using our RA software: After an intense evaluation phase, another multinational MedTec enterprise has decided to use REGULA™ for all its future submissions. In the...

Reinforcement of the ISS Team

Monday, 24 November 2014
Reinforcement of the ISS Team

The ISS Team has received reinforcement: Dr. Michel Weber ISS AG decided to strengthen its competence in clinical operation services by building a separate organizational unit lead by Dr. Michel...

Talk at the ESCRS in Amsterdam with Harald Studer

Wednesday, 13 August 2014

Harald Studer will have a lecture to a new study at the ESCRS in Amsterdam this year from 05-09 October 2013. The study was done in collaboration with the Ohio State University...