ISS AG, Integrated Scientific Services

ISS AG

ISS AG, Integrated Scientific Services provides services to medtech companies for the development of medical devices, their introduction into the market and their maintenance. Typical services include medical software development, regulatory affairs and clinical evaluation report writing, clinical research, quality management, qualification and validation. The combination of these services with scientific work methods and project management puts ISS AG into a unique position as a service provider for the medtech industry. Our services in an overview:

Global Regulatory Affairs

Worldwide Registration
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Quality Management

ISO 13485
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Clinical Operations

Clinical Studies, CRO
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Clinical Evaluations

MEDDEV 2.7.1., Rev 4
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Digital Solutions in Medical Technology

IEC 62304
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Regulatory Affairs Software

REGULA™
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Customer Feedback

  • "ISS helped us to successfully complete the renewal of our CE certificate in a decisive, efficient and competent manner with project management and technical support. In particular, the preparation of the clinical evaluation in accordance with MEDDEV 2.7/1 Rev. 4 was time-critical."
  • "Thanks to the good preparation and structured implementation of the project by ISS, the implementation of REGULA™ proved to be extremely productive. The collaboration with ISS was very pleasant and a congenial working atmosphere was created, which contributed massively to the progress of the project."
  • "ISS AG provided us with very competent and comprehensive support in the development of our cyber security strategy with a comprehensive overview of the complex regulatory situation and specific input tailored to our situation and products. With a step-by-step approach, we were able to achieve ambitious goals together in a new subject area that is still fraught with great uncertainty."
  • "ISS AG has been our partner for carrying out clinical evaluations for many years. This collaboration has greatly improved the quality of the evaluations, and every evaluation has been accepted by our Notified Body. In particular, carrying out exploratory pre-assessments prior to the actual evaluation has significantly simplified the definition of product requirements at the beginning of the R&D process. ISS AG has proven to be a flexible and reliable partner with high quality standards, even when activities are scheduled at very short notice."
  • „ISS has taken on the role of QM manager for us on an ad interim basis. With this support, we were able to improve the quality of our quality management in a short space of time and with limited effort. I was impressed by the pragmatism with which the ISS employees proceeded: the special features of our positioning and size were taken into account in the best possible way."
  • "After several rejections of our clinical investigation we contacted ISS AG. The collaboration with ISS AG resulted in the approval of the study."

Certificates