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Thema S.r.l.
Italy
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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<p><b>Thema S.r.l.</b>, part of the Complife Group, is a specialized strategic and regulatory affairs consulting company based in Imola (Bologna), Italy, with an international office in Philadelphia, USA.</p><p>Thema specializes in regulatory compliance and quality assurance for Medical Devices (MD) and In Vitro Diagnostic Medical Devices (IVD). It guides manufacturers through complex European (MDR/IVDR) and United States (FDA) pathways from the early feasibility and development stages through post-market maintenance.</p><p>Thema's management systems and training activities are certified under ISO 9001 and ISO 13485:2016, providing documented expertise in Good Manufacturing Practices (GMP) and international clearance procedures.</p>

Offer

<p>Thema delivers strategic regulatory consulting and technical documentation services for medical technologies:</p><ul><li><b>CE Certification Support (MDR & IVDR):</b> Preparation and remediation of technical documentation, Gap Analysis, risk management file construction per ISO 14971, and clinical evaluation reporting in accordance with EU Regulations 2017/745 (MDR) and 2017/746 (IVDR).</li><li><b>US FDA Registration & 510(k) Submissions:</b> Defining US market access strategies, preparing FDA Premarket Notifications 510(k), De Novo classifications, establishment registrations, device listings, and compliance with FDA Quality System Regulations (21 CFR Part 820 / QMSR).</li><li><b>Quality Management Systems & GMP:</b> Designing and implementing Quality Management Systems aligned with ISO 13485:2016, FDA cGMP, MDSAP (Medical Device Single Audit Program), and local Good Manufacturing Practices.</li><li><b>International Market Approvals:</b> Regulatory support for global filings in Latin America, Asia-Pacific, and the Middle East, including drafting Quality Technical Agreements (QTA) and acting as Local Representative.</li><li><b>Post-Market Surveillance:</b> Establishing Post-Market Surveillance (PMS) Plans, Post-Market Clinical Follow-up (PMCF) plans, and Periodic Safety Update Reports (PSUR).</li></ul>

Tags

medical devices
iso 13485
ivdr
regulatory affairs
fda 510(k)
iso 14971
ce marking mdr
qms consulting
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: Via Saragat, 5
Imola
Emilia-Romagna 40026
Italy
Get Directions
https://www.thema-med.com
Business Type: Service Provider
Ownership: Subsidiary
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