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Scandinavian Regulatory Services AB
Sweden
Medical Device Validation: V&V services for ISO 13485 compliance
Regulatory & Compliance Consulting: Design-level prep for CE/FDA/UL standards
Regulatory Affairs: Documentation and filing for global market access

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Scandinavian Regulatory Services AB (SRS) is a regulatory affairs and quality management consultancy founded in 1992 and headquartered in Danderyd, Sweden. With more than three decades of experience, the company advises manufacturers across the medical device, in vitro diagnostic, pharmaceutical, and drug-device combination product sectors.

SRS supports companies through complex Nordic, European, and US regulatory approval processes. The company provides hands-on support for developing compliant quality systems, preparing technical files for Notified Bodies, and liaising with competent authorities such as the Swedish Medical Products Agency (Läkemedelsverket) and the US FDA.

Offer

SRS provides comprehensive regulatory and compliance services, including:

  • CE Certification Guidance: Establishing and maintaining technical documentation for CE marking under MDR 2017/745 and IVDR 2017/746.
  • US FDA Registration & Approvals: Support for international product registrations, pre-market submissions, and compliance with US 21 CFR 820.
  • Product Classification & Pathways: Medical device classification, qualification, and conformity assessment pathway determinations.
  • Quality Management Systems: Developing, implementing, and updating QMS frameworks in compliance with ISO 13485:2016 and FDA QSR requirements.
  • Risk Management: Integration of risk management procedures according to ISO 14971.
  • Software & e-Health: Regulatory compliance strategies for software development, health apps, and National Medical Information systems (NMI).
  • Combination Products: Specialized regulatory bridging for drug-device and device-drug combination products.
  • Post-Market Surveillance: Drafting and updating Periodic Safety Update Reports (PSUR) and Post-Market Clinical Follow-up (PMCF) plans.
  • Audits & Authority Interaction: Supplier audits, internal audits, and representation during Notified Body or regulatory authority reviews.

Tags

ce marking
iso 13485
ivdr
regulatory affairs
mdr
risk management
fda registration
combination products
Industrial Specializations: Medical Device Validation: V&V services for ISO 13485 compliance, Regulatory Affairs: Documentation and filing for global market access, and Regulatory & Compliance Consulting: Design-level prep for CE/FDA/UL standards
Headquarter/main address: Svädvägen 23
Danderyd
Stockholm 182 33
Sweden
Get Directions
https://www.srs.se
Business Type: Service Provider
Ownership: Private
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