Medos AB

Sweden

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Medos AB is an engineering and regulatory consulting firm headquartered in Linköping, Sweden. Established in 2006, the firm assists medtech innovators, startups, and scale-ups with medical device software, electronics, and mechanical product development.

The company guides manufacturers from early development through CE marking and FDA clearance, providing technical file creation, risk management, and quality system implementation. Medos AB also developed and operates Focalcube, a proprietary electronic Quality Management System (eQMS) built specifically for medical technology companies.

Offer

Medos AB provides regulatory and technical consulting services that include:

CE Marking Advisory: Qualification, classification, and conformity assessments under MDR 2017/745 and IVDR 2017/746.
FDA Submissions: Regulatory pathway development and documentation preparation for 510(k), De Novo, and PMA filings.
Design Controls & Software Development: Software lifecycle process implementation and technical file structuring according to EN 62304 / IEC 62304.
Risk Management: ISO 14971-compliant risk analysis, FMEA, and benefit-risk evaluations.
Cybersecurity & Information Security: Design-phase cybersecurity evaluations aligned with IEC 81001-5-1, ISO 27001, and FDA cybersecurity guidelines.
Technical Documentation: Authoring and gap analysis of technical documentation according to MDR Annex II and III.
QMS Implementation: Design and audit readiness for ISO 13485:2016, FDA 21 CFR Part 820 (QMSR), and integration with the Focalcube eQMS platform.
Operational QA/RA Support: Interim Quality Manager, Regulatory Manager, or PRRC roles.

Medos AB

Offer

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