GBA Key2Compliance AB

Sweden

All business names, logos, and images are used for informational purposes only. If you are the owner of any image or content displayed and wish to remove or update it, please contact us. By claiming your listing – see link at the bottom- you can upload your official media and desired texts.

GBA Key2Compliance AB is a Swedish regulatory compliance and quality assurance consultancy specializing in medical devices, in vitro diagnostics (IVD), and pharmaceuticals. Founded in Stockholm in 1994, the company was acquired by the European laboratory group GBA Group to expand its advisory and regulatory reach across Scandinavia and international markets.The company provides strategic counsel and operational support across the full product development lifecycle, helping manufacturers navigate the requirements of the EU Medical Device Regulation (MDR 2017/745), In Vitro Diagnostic Regulation (IVDR 2017/746), and US FDA 21 CFR standards. In addition to its Stockholm headquarters, the organization operates regional offices in Lund and Gothenburg, Sweden, as well as Copenhagen, Denmark.

Offer

GBA Key2Compliance delivers comprehensive design-level and lifecycle regulatory consulting, including:<ul><li>CE Marking Strategy & Execution: End-to-end support for medical devices and IVDs under EU MDR and IVDR frameworks.</li><li>US FDA Submissions: Guidance for FDA 510(k), De Novo classifications, and PMA submissions, alongside QMSR (21 CFR Part 820) readiness.</li><li>Technical Documentation: Drafting, structuring, and auditing technical files to satisfy Notified Body and competent authority expectations.</li><li>Design & Development Controls: Establishing compliant design control processes and Design History Files (DHF).</li><li>Risk Management: Facilitation and documentation of risk analysis according to ISO 14971 standards.</li><li>Electrical Safety & Verification/Validation: Advisory services ensuring electrical safety and V&V compliance.</li><li>Software Compliance: Lifecycle processes and qualification for Medical Device Software (MDSW) under IEC 62304 and IEC 81001-5-1.</li><li>Quality Management Systems (QMS): Implementation and audit readiness for ISO 13485:2016 and FDA quality system regulations.</li><li>Authorized Representation & Roles: Person Responsible for Regulatory Compliance (PRRC) and UK Responsible Person services.</li></ul>

GBA Key2Compliance AB

Offer

Tags