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Manual and Checklists for the development of secure health apps

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ISS AG developed on behalf of eHealth Suisse a manual and checklists for the development of secure health apps. Software engineers have to ask themselves very early in the process of developing a health app, if their product falls into the category of a medical device and which regulation they have to adhere with. The manual supports the software engineers in this process. It provides practical...
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ISS Spin-off received IIb certification

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ISS spin-off, Optimo Medical AG , has received the certification for their class IIb product Optimeyes. This clears the way to use Optimeyes for very challenging operation planning in ophthalmology. To the best of our knowledge, Optimeyes is one of the first stand-alone software medical devices in Switzerland to overcome the considerable obstacle of the certification as a medical device in class...
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Event: New MedTech EU MDR/ IVDR Regulations - Consequences and Solutions (January 30th 2018)

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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 on the business performance of many companies and SMEs. All companies are strongly challenged. The first stakeholders have prepared GAP analyses to realize the tight implementation requirements by 2020 (MDR) and 2023 (IVDR)....
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ISS-Talk at the Tuttlinger Innovationsforum on October 19th

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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 market”. The fact, that we were invited for this talk shows, that there is a lot of interest for this topic. However: ISS is investing for the simplification of Regulatory Submission processes by the means of IT for a long...
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3D Printing, impact of MDR

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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 Life Science. The Regulatory Situation is not clear in many aspects, therefor the potential impact of the new European regulation is of great interest. Hansjörg Riedwyl will point out, what is already clear, what the MDR will bring and where...
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Formation – Évaluation clinique selon MEDDEV 2.7/1, Révision 4

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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 de mise en application en Suisse. Actuellement, la création d’une évaluation clinique est un défi pour l’industrie. Cette formation offre un programme ad hoc vous...
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Further clinical evaluation of ISS AG meets the requirements

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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 MEDDEV 2.7.1 rev.4 and fulfills the requirements of MEDDEV 2.7.1 rev.4" We are very pleased that we have been able to support our customers in the certification of a Class IIb implant.
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ISS AG is now a member of the BVMA e.V.

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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) which are based in Germany or German speaking countries.To make sure that each member satisfies the high quality demands, all members undergo re-auditing every three years. We are very pleased...
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ISS AG has been successfully audited as clinical Contract Research Organisation (CRO)

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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 GCP), relevant national and international GCP requirements, CRO policies and procedures, and generally accepted good practices.
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Regulatory Affairs Software – No more missed deadlines

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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, which finally results in more turnover. This article was one of the most read DeviceMed articles in November 2016. Read our article in the medical journal DeviceMed to get more information about...
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Successful application of MEDDEV 2.7/1 Rev. 4 for clinical evaluations

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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 corresponding MEDDEV 2.7/1. The absence of an updated clinical evaluation according to Rev. 4 during an audit is considered to be a major non-conformity. We have adapted our processes and practice accordingly and in the...
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Successful maintenance audit for ISO 13485

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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 allows ISS to consolidate its position as a credible service provider in the fields of software development, regulatory affairs, clinical evaluations, clinical studies (CRO) and...
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Meet the Expert Implants Interlaken

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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 implants: View of the development company and of the CRO. Link eCM Journal
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Surveillance Audit by Notified Body DQS

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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 (CRO). The successful outcome is confirming our undertakings of the last months in further developing the CRO business. The audit was closed with no deviations noted.
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«i-net Medtech After-Work Regulatory Affairs Circle» with ISS AG

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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 a year to dis­cuss given RA cases and re­la­ted ac­tua­li­ties in an open and con­struc­tive man­ner. The cir­cle is de­di­ca­ted to med­tech re­la­ted RA, we ad­dress the event to peop­le and...
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Another success for REGULA™

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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 already terminated first phase, RA processes of different locations were analysed and standards were searched and defined. The customer is seeking to harmonize and speed up RA processes globally,...
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Reinforcement of the ISS Team

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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 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...
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Talk at the ESCRS in Amsterdam with Harald Studer

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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 and compares the biomechanical effects of LASIK Flap and ReLEx Smile Cap Incisions.
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