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 specializing in Medical Devices (MD) and In Vitro Diagnostic Medical Devices (IVD). They offer partnership and support for market access and compliance on national and international levels.

**Expertise & scope**
* Strategic regulatory consultancy for MD and IVD manufacturers and distributors.
* Support for CE marking.
* Italian and European ministerial registrations.
* International registrations outside the EU.
* Local Representative services.
* International Quality and Good Manufacturing Practice (GMP).
* Training and events.

**Reputation / proof points**
* Based in Italy and the USA.

Additional information

Thema Med provides strategic regulatory consultancy, focusing on supporting clients in achieving their sales objectives through reliable and competent regulatory partnerships. Their services extend to assisting with CE marking, managing ministerial registrations within Italy and Europe, and facilitating international registrations outside the EU. They also offer Local Representative services, international Quality and GMP support, and training events. The company has a presence in both Italy and the USA.

Key Highlights

  • 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)”
  • Provides support for CE marking and international registrations outside the EU. Source
    “Supporto alla marcatura CE; Registrazioni internazionali extra-UE”
  • Offers Local Representative services. Source
    “Local Representative”

Certifications & Trust Signals

  • Established presence in Italy and the USA. Source
    “Thema srl Via Saragat, 540026 Imola (BO) – Italia; Thema Corp B+Labs c/o Cira Center 2929 Arch Street, Floor 4 Philadelphia, PA 19104 – U.S.A.”

Buyer Snapshot

Best for
  • Manufacturers and distributors of Medical Devices (MD) and IVDs
  • Companies seeking support for CE marking and international registrations
How engagement typically works
  • Strategic partnership for market access
  • Competent regulatory support
Typical deliverables
  • CE marking support
  • Italian and European ministerial registrations
  • International registrations (extra-EU)
  • Local Representative services
Good to know
  • Best when requiring strategic guidance for market access and regulatory compliance for medical devices and IVDs.

Pricing

Model: Onboarding + annual retainer
HQ: Imola, IT
Languages: English, German, French
Timezones: Europe/Zurich
Claim status: Listed

Services & Capabilities

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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
true
Vigilance Contact Support
Yes
Can Be Named On Label
Yes
Swiss Entity Canton Or Region
CH
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