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 strategic regulatory consultancy that supports manufacturers and distributors of Medical Devices (MD) and In Vitro Diagnostic Devices (IVD) in accessing national and international markets. Their aim is to act as a reliable and competent partner in the regulatory field to help clients achieve their sales objectives.
**Expertise & scope**
- Strategic regulatory consultancy
- Support for CE marking
- Italian and European ministerial registrations
- International registrations outside the EU
- Local Representative services
- International Quality and GMP
- Training and events
**Reputation / proof points**
- Offers services for the Italian market.
- Provides international registration support outside the EU.
- Operates as a Local Representative.
Thema Med is a strategic regulatory consultancy that supports manufacturers and distributors of Medical Devices (MD) and In Vitro Diagnostic Devices (IVD) in accessing national and international markets. Their aim is to act as a reliable and competent partner in the regulatory field to help clients achieve their sales objectives.
**Expertise & scope**
- Strategic regulatory consultancy
- Support for CE marking
- Italian and European ministerial registrations
- International registrations outside the EU
- Local Representative services
- International Quality and GMP
- Training and events
**Reputation / proof points**
- Offers services for the Italian market.
- Provides international registration support outside the EU.
- Operates as a Local Representative.
Additional information
Thema Med's services extend to providing a Local Representative function, crucial for market access in various regions. They specialize in strategic regulatory consultancy, assisting clients with CE marking, and managing ministerial registrations both within Italy and across Europe. For companies looking beyond the EU, Thema Med also offers support for international registrations. Their expertise encompasses Quality and GMP standards, alongside providing training and events related to regulatory affairs.
Key Highlights
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Specializes in strategic regulatory consultancy for Medical Devices and IVDs.
Source
“THEMA offre 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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Provides support for CE marking and ministerial registrations in Italy and Europe.
Source
“Supporto alla marcatura CE; Registrazioni ministeriali italiane ed europee”
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Offers international registration services for markets outside the EU.
Source
“Registrazioni internazionali extra-UE”
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Acts as a Local Representative for market access.
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 regulatory support for Medical Devices and IVDs.
- Manufacturers and distributors targeting Italian and European markets.
- Businesses requiring international registration assistance.
How engagement typically works
- Partnership-based regulatory support.
- Strategic guidance for market access.
Typical deliverables
- CE marking support.
- Italian and European ministerial registrations.
- International registrations (outside EU).
- Local Representative services.
Good to know
- Best when engaging a consultancy for strategic regulatory guidance and market access support.
Pricing
Model:
Onboarding + annual retainer
HQ:
Imola, IT
Languages:
English, German, French
Timezones:
Europe/Zurich
Claim 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
Swiss Entity Canton Or Region:
CH
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
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