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MedQtech 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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MedQtech AB is a Swedish medical device regulatory and quality management consulting firm based in Grebbestad, with an additional office location in Sundsvall. The company is certified to SS-EN ISO 13485:2016 by RISE Research Institutes of Sweden for medical device consultancy and eQMS solutions.

MedQtech guides medical technology manufacturers through the regulatory pathways necessary to obtain market clearance in both the European Union and the United States, supporting clients from initial device classification through to Notified Body and FDA reviews. The company also offers MedQdoc, a turnkey cloud-based eQMS platform tailored for medical device manufacturers.

Offer

MedQtech AB delivers specialist regulatory affairs and quality management services, including:

  • CE Marking Support: End-to-end guidance through the CE marking process under EU MDR (2017/745) and IVDR (2017/746).
  • US Regulatory Compliance: Preparation for FDA registrations, 510(k) applications, and alignment with FDA 21 CFR Part 820 (QSR/QMSR) and Part 11.
  • Technical Documentation: Gap analysis, compilation, and maintenance of Technical Files and Design Dossiers.
  • Design Controls & Usability: Compliance advisory according to IEC 62304 (medical device software lifecycle) and IEC 62366-1 (usability engineering).
  • Risk Management: ISO 14971 risk management integration and facilitation throughout the product lifecycle.
  • Quality Management System Readiness: Implementation and certification readiness for ISO 13485:2016 systems, including internal audits and supplier audits.
  • Regulatory Roles: Acting as Person Responsible for Regulatory Compliance (PRRC) under MDR/IVDR Article 15.
  • eQMS Solutions: Delivery of MedQdoc, a platform featuring over 130 pre-defined templates for regulatory compliance.

Tags

ce marking
iso 13485
ivdr
iec 62304
mdr
iso 14971
fda compliance
eqms
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: Rörviksvagen 40A
Grebbestad
Västra Götaland 457 95
Sweden
Get Directions
https://medqtech.com
Business Type: Service Provider
Ownership: Private
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