Seleon
seleon GmbH
seleon GmbH is a service partner for medical technology companies, offering end-to-end product development from idea to market launch. They specialize in development, consulting, and production of complex medical technology systems.
seleon GmbH is a dedicated service partner for medical technology companies, transforming innovative ideas into high-quality products at the forefront of the industry. Their comprehensive end-to-end offering covers all phases of product development, from initial concept to market launch. With a team of experienced engineers, physicians, and QM experts, seleon leverages extensive international project experience in development, manufacturing, and regulatory affairs to benefit their clients. The company excels in the production of highly specialized devices, ensuring perfection through qualified personnel and modern equipment. Their services extend to Material Compliance, Sustainable Medical Technology, Training, Regulatory & IP Due Diligence, Startup Consulting, taking on regulatory roles, approval consulting, digitalization, and lifecycle management. seleon GmbH is committed to innovation and quality, providing expert support in system development, software/firmware, electronics, mechanics/mechatronics, documentation, testing, project management, and technical consulting. They aim to be a comprehensive resource for medical technology development and production needs.
About
**Who they are**
Seleon GmbH is a service partner for medical technology companies, offering end-to-end product development from idea to market launch. They specialize in the development, consulting, and production of complex medical technology systems.
**Expertise & scope**
* System development
* Software/Firmware
* Electronics
* Mechanics/Mechatronics
* Documentation and testing
* Project management
* Lifecycle management / Technical consulting
* Material Compliance
* Sustainable Medical Technology
* Training and courses
* Regulatory & IP Due Diligence Services
* Start-up consulting
* Assumption of regulatory roles
* Approval consulting / Regulatory Affairs
* Digitalization
**Reputation / proof points**
* Extensive expertise based on a variety of international development, manufacturing, and approval projects.
Seleon GmbH is a service partner for medical technology companies, offering end-to-end product development from idea to market launch. They specialize in the development, consulting, and production of complex medical technology systems.
**Expertise & scope**
* System development
* Software/Firmware
* Electronics
* Mechanics/Mechatronics
* Documentation and testing
* Project management
* Lifecycle management / Technical consulting
* Material Compliance
* Sustainable Medical Technology
* Training and courses
* Regulatory & IP Due Diligence Services
* Start-up consulting
* Assumption of regulatory roles
* Approval consulting / Regulatory Affairs
* Digitalization
**Reputation / proof points**
* Extensive expertise based on a variety of international development, manufacturing, and approval projects.
Additional information
Seleon's approach integrates engineering, medical, and quality management expertise, drawing from extensive international project experience. They offer comprehensive support across the entire product lifecycle, from initial concept through to market launch. Their services are designed to assist medical technology companies in navigating complex development, regulatory, and production challenges.
Key Highlights
-
Offers end-to-end product development from idea to market launch.
Source
“offering end-to-end product development from idea to market launch.”
-
Specializes in development, consulting, and production of complex medical technology systems.
Source
“offering end-to-end product development from idea to market launch. They specialize in development, consulting, and production of complex medical technology systems.”
-
Provides a wide range of services including Material Compliance, Regulatory Affairs, and Start-Up Consulting.
Source
“Material Compliance; Nachhaltige Medizintechnik; Schulungen und Trainings; Regulatory & IP Due Diligence Services; Start Up Beratung; Übernahme regulatorischer Rollen; Zulassungsberatung / Regulatory Affairs; Digitalisierung; Lifecycle Management / Technisches Consulting”
Certifications & Trust Signals
-
Leverages expertise from a variety of international development, manufacturing, and approval projects.
Source
“Wir sind Ingenieure, Ärzte und QM-Experten, deren fundiertes Fachwissen auf einer Vielzahl von internationalen Entwicklungs-, Fertigungs- und Zulassungsprojekten basiert.”
Buyer Snapshot
Best for
- Medical technology companies seeking end-to-end product development support.
- Companies requiring specialized consulting in regulatory affairs and market access.
How engagement typically works
- Project-based development and consulting.
- Assumption of regulatory roles.
Typical deliverables
- Developed medical technology systems.
- Regulatory strategy and submission support.
- Material compliance assessments.
- Training and documentation.
Good to know
- Best when requiring specialized expertise in complex medical technology systems.
HQ:
Heilbronn, Germany
Languages:
English, German
Timezones:
Europe/Berlin
Status:
listed
Services & Capabilities
PRRC MDR (EU MDR) | PRRC Medical Device Service | Compare Providers & Get Quotes
Jurisdictions:
EU
Countries:
DE, AT, FR, EU
Industries:
Medical devices, IVD, SaMD, Manufacturing
Portfolio:
26-100
Onboarding time:
3–14 days
Pricing model:
Onboarding + annual retainer
Starting from:
EUR 3,200
Included services:
PRRC appointment support, Lifecycle compliance oversight, Change-impact escalation, PMS/vigilance coordination support
Named PRRC:
No
Availability Hours:
Business hours
PRRC Qualification Summary:
The company consists of experienced engineers, doctors, and QM experts with profound expertise based on a variety of international projects in development, manufacturing, and approval. They offer end-to-end services covering all phases of product development, from idea to market launch. Their services include development, consulting, production, system development, software/firmware, electronics, mechanics/mechatronics, documentation/testing, project management, and lifecycle management/technical consulting. They also provide services related to material compliance, sustainable medical technology, training, regulatory & IP due diligence, startup consulting, taking over regulatory roles, approval consulting/regulatory affairs, and digitalization.
Additional prrc_service Details
Included Services Detailed
Appointment and mandate support for outsourced PRRC coverage (seed scope), Lifecycle compliance oversight aligned to Article 15 activities (seed scope), Change-impact triage and escalation support (seed scope), Periodic compliance reporting to management (seed scope)
Excluded Services
Notified Body decision-making on conformity assessment, Acting as Legal Manufacturer unless separately contracted, Commercial distribution or importer/distributor operations
Onboarding Steps
Intake → scope & device class mapping → responsibilities matrix → workflow setup → ongoing PRRC coverage
Coverage Details
PRRC availability set to Custom with defined escalation path (seed summary).
Supports MDR
true
PRRC Qualification Summary
The provider's team consists of engineers, physicians, and QM experts with extensive knowledge from international projects.
Regulatory Experience
Extensive experience across international development, manufacturing, and approval projects.
Supports IVDR
true
