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Sandra Item and Bernhard Bichsel as guest experts on the MDR postponement

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On Thursday, July 2nd 2020 (16:00-17:00), two of ISS AG Senior experts will actively participate in the 1 st SwAPP web-interview regarding the impact of the MDR postponement on Medtech and Pharma. This event takes place on the web in the form of presentations and an interview. Sandra Item, Head of Regulatory Affairs & Knowledge Management, and Bernhard Bichsel, Senior Consultant and Strategic...
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Learning more about PMCF ?

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Register here for a free hands-on webinar on Wednesday, 10 June 2020. Thanks to the Clinical Experts of our CRO, we have designed a compact webinar about Post-Market Clinical Follow-up (PMCF) methodology while benefiting from Bernhard Bichsel's insight into the current Regulatory context of clinical data acquisition!
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Breaking News – MDR DOA postponed until 26. May 2021

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The COVID-19 pandemic is having a significant impact on the medical device industry, including the preparations for the upcoming implementation of the MDR. On April 17 th the European Parliament voted in favour of the Commission’s proposal to postpone the date of application of the Medical Devices Regulation (MDR) by one year to 26 May 2021. Today the amendment to postpone the DOA was published...
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ISS AG participates in the fight against SARS-CoV-2

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ISS AG participates in the fight against SARS-CoV-2 by assessing new tests on the market for their regulatory quality and clinical validation. We support our customers in accelerating the market approval of vital medical devices (eg. ventilators) or IVD.
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ISS AG Medtech Bootcamp – New talents available for your company

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“After 4 weeks of the training I can say that the ISS bootcamp is one of the greatest experience in my professional working life.” Serhat Daye This pilot initiative to cope with acute shortage of Medtech experts took successfully place in March and during an intensive month of training, carefully selected boot campers received the essential knowledge to be able to work in Q or RA departments or...
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Bernhard Bichsel will join ISS as per May 1st 2020.

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Bernhard led Swissmedic’s Medical Device Department during the past 7 years and was a member of various European Working groups. Among others, he was a very active member of the CAMD Executive Group ( https://www.camd-europe.eu ), where he was heavily involved in MDR/IVDR implementation activities. Originally, he started-off as an Electrical Engineer, focused on production, verification and...
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ISS MedTech Bootcamp - Information Week 3

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Due to the present context (COVID-19), we slightly adapted the program of our Medtech Bootcamp. We decided that the lectures will be held remotely (webinar) from today on. Only the crews who remain welded and join forces can keep the boat floating and maintain the right heading…
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ISS MedTech Bootcamp: Impressions of yesterday's topic: Usability, IEC 62366.

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It was very interesting to have Andreas Baier, Director & Principal of Ergonomics Factory GmbH as our guest speaker. More about our evening program: https://www.iss-ag.ch/de/bootcamp-event-program If you would like to participate, please send us an e-mail: bootcamp@iss-ag.ch
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Week 2 of the ISS MedTech Bootcamp

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A big thank you to Thomas Bohnen, CEO Qualitätsplan Lübeck, DE for the interesting speech yesterday evening about how 60601-1 tests are set up in practice. More about our evening program: https://www.iss-ag.ch/bootcamp-event-program If you would like to participate, please send us an e-mail: bootcamp@iss-ag.ch
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Hansjörg Riedwyl as guest lecturer at the ETH Zurich

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On Thursday, 19 March 2020 (10:15 am – 12:00 am), Hansjörg Riedwyl, CEO of Integrated Scientific Services in Biel and expert in business development, will give a guest lecture at the ETH Zurich (Maschinenlaboratorium, Sonneggstrasse 3, Room ML H 37.1). The lecture is about Apps and Medical Device Software. Digital health interventions offer a lot of new opportunities for all involved, not only...
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Bootcamp Day 2: Visit at Bern University of Applied Sciences

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Thank you Bern University of Applied Sciences for letting us have a sneak peek into you interesting living lab of medical informatics. And a big thank you to Thomas Bürkle for the interesting presentation.
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Searching for new Talents in Q/RA: we are selecting and training new talents for Q/RA for the Swiss MedTech Industry.

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We are searching for new talents in Q/RA for the Swiss MedTech Industry. If you are selected for our bootcamp, which will take place March 2 nd to March 27 th in Biel, you can benefit from our high density (1 month) training program. This includes MedTech topics (RA, Q), industry insights, soft skill (e.g. Project Management) as well as an exam at the end of the bootcamp. The bootcamp is free...
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Join the first MedTech bootcamp, taking place March 2nd to March 27th 2020 in Biel

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If you are FH/UNI graduate, junior professional or a newcomer to Medtech of any age, highly motivated to work in a dynamic and international environment and if you have an interest in medicine and technology, join the first MedTech bootcamp, taking place March 2nd to March 27th 2020 in Biel. The bootcamp will give you the necessary hard- and soft-skills for a career within MedTech Industry. The...
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Hansjörg Riedwyl and Matthias Steck as speakers at the Regulatory Journey of Health Tech Cluster Switzerland

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The Regulatory Journey will take place in Schlieren on Thursday, 16 January 2020 at 14.00. The event will deal with relevant regulatory aspects. After a keynote on the topic "Final sprint MDR - Suggestions for the last mile", further topics will be discussed in depth in nine workshops and the questions of the participants will be answered. ( source ). One of the workshops will be conducted by...
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Hansjörg Riedwyl as guest lecturer at the University of St. Gallen

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On Wednesday, 16 October 2019 (16.15 - 18.00) Hansjörg Riedwyl, CEO of ISS AG in Biel, will give a guest lecture at the University of St. Gallen , Dufourstrasse 50 (room 09-011). The topic will be "Apps and other Software as Medical Device". Digital health interventions offer many new opportunities to all involved, but there are also hurdles to consider. This means that digital health...
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ISS-AG is co-author of the strategy paper " The future of previous OEM PLM constellations in the Medical Technology Industry", published by MedicalMountains GmbH.

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With the application of the EU-MDR, the OEM/PLM relationships that have been frequently practiced so far will be a thing of the past. So far, the OEM ("Original Equipment Manufacturer") has been able to concentrate on the development and manufacture of its products and sell them without a name to a PLM ("Private Label Manufacturer") who was the sales expert. All he had to do was apply his own...
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Hansjörg Riedwyl Speaker at the MDR Support Panel - Third State Regulation

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On October 23rd, 2019 the MDR Support Panel will take place in the new sitem-insel building, Freiburgstrasse 3, 3010 Bern. The background to this event is the adoption of the new EU legislation in the field of medical devices (MDR), for which regulatory issues in particular have not yet been clarified. The topic will be the regulation of third countries. As adoption of the framework agreement is...
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Hansjörg Riedwyl speaker at Medtech 2020 and Beyond: Tips for Survival in Europe’s New Medtech Environment Wednesday, October 30, Hotel Bellevue Palace, Bern

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Hansjörg Riedwyl, CEO of ISS AG, Integrated Scientific Services, will have the opportunity to speak at the Event “Medtech 2020 and Beyond: Tips for Survival in Europe’s New Medtech Environment”, which will take place Wednesday, October 30 at the Hotel Bellevue Palace in Bern. The event addresses management and business development and focusses on strategic impact of the new EU Medical Devices...
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Successful OEM/PLM Symposium in Tuttlingen

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Many business models in the Tuttlingen region are based on OEM/PLM constellations. Here the MDR (EU 2017/745) is a special challenge. At a symposium, the various aspects and possibilities were discussed and supplemented with concrete examples from practice. In a keynote speech, Hansjörg Riedwyl presented five different strategic options and made assessments on feasibility and the risks involved.
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Successful start of PEDeDose

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The „Software as Medical Device“ (short: SaMD) product PEDeDose of the company PEDeus launched successfully in March 2019. PEDeDose supports healthcare professionals in prescribing pediatric medication and provides patient-specific information. The software can be accessed by any mobile- and desktop browser, or be transparently integrated into an existing system by using its web service. To...
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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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