Thema S.r.L
Thema is a company specializing in regulatory consultancy for medical devices and IVDs, providing strategic regulatory advice, support for CE marking, registration, quality management, and local representation. They aim to support companies in navigating complex regulatory environments and ensuring compliance across different markets worldwide. They also offer training, updates on regulatory changes, and strategic partnerships to expand their global reach.
Industries
Nr. of Employees
small (1-50)
Thema S.r.L
Products
Checklist labelling MDR
Checklist to verify completeness and compliance of device labelling information according to MDR (EU) 2017/745 requirements.
QTA Legal Agent China template
Contract template defining technical‑regulatory and quality system responsibilities between a manufacturer and a legal agent for China regulatory representation.
Checklist prescreening 510(k)
Checklist to verify formal conformity of documents intended for a 510(k) submission to the US regulatory authority.
Clinical evaluation infographic
Infographic summarizing the clinical evaluation process required by MDR and relevant guidance documents, intended as an informational resource for manufacturers and assessors.
Checklist labelling MDR
Checklist to verify completeness and compliance of device labelling information according to MDR (EU) 2017/745 requirements.
QTA Legal Agent China template
Contract template defining technical‑regulatory and quality system responsibilities between a manufacturer and a legal agent for China regulatory representation.
Checklist prescreening 510(k)
Checklist to verify formal conformity of documents intended for a 510(k) submission to the US regulatory authority.
Clinical evaluation infographic
Infographic summarizing the clinical evaluation process required by MDR and relevant guidance documents, intended as an informational resource for manufacturers and assessors.
Services
Regulatory strategy, gap analysis and program planning to align device development with applicable national and international regulations; support for dossier preparation and submissions.
Assistance preparing technical files, conformity assessment evidence and interactions with notified bodies for MDR/IVDR certification.
Implementation and improvement of QMS and GMP‑aligned processes for device and IVD manufacturing and supply; audit and inspection preparedness.
Provision of authorized representative roles and contractual/legal agent services to enable market access and local regulatory compliance in target countries.
Public and customized instructor‑led training programs covering MDR/IVDR requirements, clinical evaluation, post‑market surveillance, ISO standards, software validation, biocompatibility and usability topics; in‑house courses tailored to company needs.
Pre-built templates, checklists and SOPs for labeling, technical documentation, UDI, risk management, PMS and other regulatory tasks available as digital downloads.
Regulatory strategy, gap analysis and program planning to align device development with applicable national and international regulations; support for dossier preparation and submissions.
Assistance preparing technical files, conformity assessment evidence and interactions with notified bodies for MDR/IVDR certification.
Implementation and improvement of QMS and GMP‑aligned processes for device and IVD manufacturing and supply; audit and inspection preparedness.
Provision of authorized representative roles and contractual/legal agent services to enable market access and local regulatory compliance in target countries.
Public and customized instructor‑led training programs covering MDR/IVDR requirements, clinical evaluation, post‑market surveillance, ISO standards, software validation, biocompatibility and usability topics; in‑house courses tailored to company needs.
Pre-built templates, checklists and SOPs for labeling, technical documentation, UDI, risk management, PMS and other regulatory tasks available as digital downloads.
Expertise Areas
- Regulatory compliance for medical devices and IVD (EU and extra‑EU)
- Quality management systems and GMP alignment for devices
- MDSAP compliance and audit readiness
- International market access and authorized representation
Key Technologies
- ISO 13485 (including A11 amendment)
- ISO 14971 risk management
- IEC 62304 software lifecycle and validation
- EN 62366-1 usability engineering
News & Updates
Opportunities for medical device manufacturers in South Africa.
The UK Medicines and Healthcare products Regulatory Agency (MHRA) extends the acceptance period for CE-marked medical devices.
Opportunities for medical device manufacturers in South Africa.
The UK Medicines and Healthcare products Regulatory Agency (MHRA) extends the acceptance period for CE-marked medical devices.