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ISS AG, Integrated Scientific Services
Switzerland
Regulatory & Compliance Consulting: Design-level prep for CE/FDA/UL standards

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ISS AG, Integrated Scientific Services is an ISO 13485-certified Swiss service and consulting company founded in 2003 and based in Bern. Employing approximately 30 specialized experts, ISS AG advises MedTech and in vitro diagnostics companies on engineering compliance, regulatory approvals, clinical evidence, and quality management systems.

ISS AG provides targeted support during the design and development phases of medical devices and medical software, assisting manufacturers in meeting design verification requirements for CE certification in Europe, FDA approvals in the United States, and market registrations in over 80 countries worldwide.

Offer

ISS AG provides specialized technical, regulatory, and engineering compliance services:

  • Design Verification & Technical Documentation: Creation and review of technical dossiers compliant with EU MDR 2017/745, EU IVDR 2017/746, and US FDA requirements, encompassing General Safety and Performance Requirements (GSPR) matrices.
  • FDA Submissions & Change Management: Support for FDA 510(k), PMA applications, and Predetermined Change Control Plans (PCCP) for evolving medical technologies.
  • Medical Device Software Development (MDSW): Full software lifecycle development and documentation according to IEC 62304 and IEC 82304-1 for cloud, web, and mobile medical applications.
  • Medical Cybersecurity Advisory: Cybersecurity requirements definition, threat modeling, architecture assessment, and data integrity verification aligned with FDA and European guidance.
  • Quality Management Systems (QMS): Setup, optimization, and auditing of quality management systems compliant with ISO 13485, 21 CFR 820 / QMSR, and MDSAP.
  • Clinical & Performance Evaluations: Preparation of Clinical Evaluation Plans (CEP) and Reports (CER) under MDR Annex XIV and IVD performance evaluations.

Tags

ce marking
iso 13485
iec 62304
regulatory consulting
cybersecurity
fda approval
medical device software
Industrial Specializations: Regulatory & Compliance Consulting: Design-level prep for CE/FDA/UL standards
Headquarter/main address: Nordring 4A
Bern
Bern 3013
Switzerland
Get Directions
https://www.iss-ag.ch
Business Type: Service Provider
Ownership: Private
Employees: 10 - 49
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