THEMA Corp.2024-05-02T14:32:13+02:00

Let’s Take Care Beyond the Boundaries


THEMA provides strategic-regulatory consulting services to companies operating in the medical device, in vitro diagnostic medical device, and related regulated fields.

THEMA aims to help its Clients to achieve their own marketing goals by using a reliable, competent and regulatory-specialized partner.

Services for the United States

  • Strategic-Regulatory Consulting: our experts are well-versed in navigating complex regulatory changes, which are essential for the successful operation within the medical sector.

  • FDA pre-market submission: Thema’s experts support manufacturers through the process of obtaining 510(k), deNovo, and PMA procedures.

  • U.S. Representative: we offer services as Contact Person, and Post-Market Surveillance Representative.

  • Quality: we provide comprehensive assistance in the implementation of requirements such as 21 CFR 820 and MDSAP.

  • Training: Thema’s experts can provide the necessary training to facilitate growth and continuous improvement.

Services for the European Union

  • Strategic-Regulatory Consulting: our experts closely monitor regulatory changes essential for successful operations in the medical field.

  • CE Marking: Thema’s experts guide manufacturers through the process of obtaining the CE marking for Medical Devices and IVDs.

  • European Ministerial Registrations: we provide support for the Eudamed database and notifications and registrations at the Ministries of Health of the EU Member States.

  • Local Representative: we offer EU Authorized Representative and post-market surveillance services tailored to meet regulatory requirements.

  • Quality: our services encompass full assistance in implementing the GMP Quality System in accordance with ISO 13485:2016.

Services for non US countries

  • US Agent

  • US Initial Importer

Market worldwide

Thema is able to support to market devices in the most important foreign countries.

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Latest Updates

Contact us

Thema US Company Branch
Philadelphia, Pennsylvania

B+Labs c/o Cira Center
2929 Arch Street,
Floor 4
Philadelphia, PA 19104

+1 215-845-9459

How can we help you?

Fill the form and get in touch with our US Manager to explain your needs in a free 1h consultation

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