Thema Med
Thema srl
Thema Med is a leading regulatory consultancy specializing in Medical Devices and IVDs. They offer strategic guidance and support for market access and compliance in Italy, Europe, and internationally.
Thema Med provides expert strategic regulatory consulting services for companies manufacturing or distributing Medical Devices (MD) and In Vitro Diagnostic Medical Devices (IVD) in both national and international markets. Their primary goal is to partner with clients, offering reliable and competent regulatory support to help them achieve their sales objectives. The company focuses on navigating the complex regulatory landscape, including MDR (EU) 2017/745 updates and the implications of Brexit for Swiss market access. They offer comprehensive support for CE marking, Italian and European ministerial registrations, and international registrations outside the EU. Additionally, Thema Med provides services for Local Representation, Quality and GMP compliance, and training and events. With a mission to save lives and preserve health, Thema Med is dedicated to enabling clients to bring safe, effective, and high-quality products to market. They aim to be a key part of a system that promotes information and training in the medical field, ensuring access to adequate treatments and products worldwide.
About
**Who they are**
Thema Med is a regulatory consultancy specializing in Medical Devices and IVDs, offering strategic guidance for market access and compliance. They focus on supporting manufacturers and distributors.
**Expertise & scope**
* Strategic regulatory consultancy for Medical Devices (MD) and In Vitro Diagnostic Medical Devices (IVD).
* Support for CE marking.
* Italian and European ministerial registrations.
* International registrations outside the EU.
* Acting as a Local Representative.
* International Quality and Good Manufacturing Practice (GMP) support.
* Training and events.
**Reputation / proof points**
* Offers services for market access in Italy, Europe, and internationally.
Thema Med is a regulatory consultancy specializing in Medical Devices and IVDs, offering strategic guidance for market access and compliance. They focus on supporting manufacturers and distributors.
**Expertise & scope**
* Strategic regulatory consultancy for Medical Devices (MD) and In Vitro Diagnostic Medical Devices (IVD).
* Support for CE marking.
* Italian and European ministerial registrations.
* International registrations outside the EU.
* Acting as a Local Representative.
* International Quality and Good Manufacturing Practice (GMP) support.
* Training and events.
**Reputation / proof points**
* Offers services for market access in Italy, Europe, and internationally.
Additional information
Thema Med positions itself as a reliable and competent partner to help clients achieve their sales objectives through regulatory expertise. They provide support for various registration processes, including Italian, European, and international markets outside the EU. Their services extend to quality management and GMP, as well as training and events, indicating a comprehensive approach to regulatory affairs for medical device companies.
Key Highlights
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Specializes in strategic regulatory consultancy for Medical Devices and IVDs.
Source
“Servizi di consulenza strategico-regolatoria ad aziende produttrici o distributrici di Dispositivi Medici (DM) e Dispositivi Medico-Diagnostici in Vitro (IVD)”
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Offers support for CE marking and international registrations outside the EU.
Source
“Supporto alla marcatura CERegistrazioni internazionali extra-UE”
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Provides Italian and European ministerial registration services.
Source
“Registrazioni ministeriali italiane ed europee”
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Acts as a Local Representative.
Source
“Local Representative”
Certifications & Trust Signals
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Established presence in regulatory consultancy for medical devices.
Source
“THEMA offre servizi di consulenza strategico-regolatoria ad aziende produttrici o distributrici di Dispositivi Medici (DM) e Dispositivi Medico-Diagnostici in Vitro (IVD)”
Buyer Snapshot
Best for
- Companies seeking strategic regulatory guidance for Medical Devices and IVDs.
- Manufacturers and distributors needing support with market access in Italy, Europe, and internationally.
- Entities requiring assistance with CE marking and various registration processes.
How engagement typically works
- Partnership-based approach to achieve sales objectives.
- Providing strategic and competent regulatory support.
Typical deliverables
- Strategic regulatory consultancy reports.
- Support for CE marking documentation.
- Completed ministerial registrations (Italian, European, international).
- Local Representative services.
- Quality and GMP compliance guidance.
- Training materials and event participation.
Good to know
- Best when requiring specialized knowledge in Medical Device and IVD regulations.
Pricing
Model:
Onboarding + annual retainer
HQ:
Imola, IT
Languages:
English, German, French
Timezones:
Europe/Zurich
Status:
listed
Services & Capabilities
Best CH-REP (Swiss Authorized Rep) | Compare & Get Quotes
Jurisdictions:
CH
Countries:
CH
Industries:
Medical devices, IVD
Portfolio:
26-100
Onboarding time:
1–5 days
Pricing model:
Onboarding + annual retainer
Starting from:
CHF 2,500
Included services:
Swissmedic contact point handling, Vigilance and incident reporting coordination, Labeling/packaging CH-REP information alignment, Mandate administration and documentation availability
Device Classes Supported:
Class I, Class IIa, Class IIb, Class III, IVD
Swiss Local Contact:
No
Labeling Support:
No
Can Be Named On Label:
No
Vigilance Contact Support:
No
Additional ch_rep Details
Included Services Detailed
Initial portfolio intake and mandate setup for Swiss representation, Operational workflow for Swissmedic queries and manufacturer responses, Support for labeling text placement adjacent to the CH-REP symbol and address details, Coordination of vigilance reporting and field safety corrective actions
Excluded Services
Notified Body certification services, Legal representation in disputes, Distributor commercial management
Onboarding Steps
Thema Med highlights the necessity of appointing a Swiss AR by specific deadlines, such as July 31, 2022, for systems and procedure packs, indicating a structured approach to compliance timelines.
Local Entity Details
Swiss-based legal entity available to act as CH-REP under MedDO/IvDO (seed summary).
Device Classes Supported
All device classes (implied by MDR/IVDR support)
Supports MDR
Yes
Supports IVDR
Yes
Swiss Local Contact
Yes
Vigilance Contact Support
Yes
Can Be Named On Label
Yes
Swiss Entity Canton Or Region
CH
