We support manufacturers of medical devices and IVDs in navigating a dynamic regulatory environment with a clear goal: to provide direction and develop sustainable solutions. Our team brings together expertise, experience, and diverse perspectives. What unites us is our commitment to guiding our clients through complex challenges, with structure, clear communication, and genuine engagement. This approach allows us to build trust-based partnerships, offering lasting solutions and fostering confidence in our processes.
Understanding complexity. Providing guidance. Moving forward together.
Leadership Team
Sandra Item
Co-CEO
Bernhard Bichsel
Co-CEO
Julie Tantau
Head of Clinical Operations
Nina Nowka
Head of Regulatory Affairs
Deborah Rossier
Head of Quality & Engineering
Kathrin Abegg
Head of Clinical and Scientific Affairs
Our Partnerships and Memberships
We collaborate with professionals and organisations to share knowledge and develop practical solutions for the MedTech industry. We also collaborate with ETH Zurich and the Institute for Marketing and Customer Insight at HSG , sharing our expertise in seminars and courses.
ISS AG in Figures
2003
foundation
~30
experts
+10'000
registered medical devices
Our Story
From Startup to Established Service Provider in the Medical Technology Industry
Our journey began on June 26, 2003, with three founders and two employees. Today, we have 30 staff members and cover all key areas related to regulatory compliance for medical devices and IVDs.
Foundation
ISS AG was founded as a service company with a focus on the medical technology industry. Business areas: Knowledge Management, Regulatory Affairs, worldwide product registrations, and medical software development.
2003
ISO Certification
We have been certified in ISO 13485 since this year. This is the quality management system standard in the medical device industry. The certification process provided us with firsthand experience of the requirements needed to achieve this certification.
2009
Clinical Studies
We have deliberately chosen to strengthen our team in the CRO sector and offer additional services related to clinical studies. This was in response to a growing customer demand, allowing us to expand our offerings in the medical technology field.
2014
Corporate Services
A new strategy was developed, resulting in the creation of the Corporate Services division. This area brings together services related to regulatory procedures (Paralegal Services) and M&A activities (Scientific Due Diligence), where we provide targeted support with our expertise.
2020
Management Buyout (MBO)
During the course of an MBO, ownership at ISS AG changed, and the management was restructured. Sandra Item and Bernhard Bichsel assumed leadership of the company as Co-CEOs.
2022
New Office in Bern
In March 2025, we moved into our new, modern office in the heart of Bern.
2025
Our certificates
ISO 13485
The company ISS AG was certified according to ISO 13485 in May 2009. Our scope allows us to execute to the following services for you under the implemented quality management system:
– Development and development services for hardware and embedded software for medical products as well as stand-alone software as medical products.
– Design and development verification and validation
– Clinical evaluations
– Clinical studies and PMCF studies
– Technical documentation of medical devices
ICH-GCP BVMA e.V.
ISS AG has been accepted as a member of the BVMA e.V. in November 2016. 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 about the admission and are convinced that we will continue to offer our customers an excellent service in the area of clinical studies.
ISS AG, Integrated Scientific Services
Nordring 4A
3013 Bern
Switzerland
Nordring 4A
3013 Bern
Switzerland
©
2025
ISS AG, Integrated Scientific Services