Legal manufacturer service provider that assumes the responsibility and certification of medical devices according to MDR
bytec Legal Manufacturer GmbH
EschweilerNew on Amplifa
About bytec Legal Manufacturer
bytec Legal Manufacturer GmbH in Eschweiler is a service provider for the medical technology industry and operates as an external legal manufacturer (Legal as a Service) for medical devices. The company assumes responsibility for products of customers, including those in the fields of ophthalmology, anesthesia, and urology, supporting them throughout the entire device lifecycle up to and beyond the CE mark. The portfolio of services includes, alongside the Legal Service, the role of EU Authorized Representative for companies from outside the EU, the establishment of tailored Quality Management Systems according to ISO 13485 and MDR, audit support, and Regulatory Affairs consulting on classification, clinical data, EUDAMED, and the MDD-MDR transition. Additionally, bytec LM provides qualified personnel for key roles such as QMB (Quality Management Representative) and PRRC (Person Responsible for Regulatory Compliance) and handles tasks such as market surveillance, Vigilance, PMS, and the archiving of Technical Files. According to the imprint, the company is registered as a GmbH in the Commercial Register Aachen (HRB 17511) and is a member of digitalHUB Aachen.
- Site
- Eschweiler
- Processes
- Legal Service (Legal Manufacturer / EU Representative), Quality Management Consulting (QM System according to ISO 13485, Audit Support), Regulatory Affairs Consulting (MDR, IVDR, EUDAMED, Classification, Clinical Data, Launch Strategy), Assumption of Responsibilities (QMB, PRRC, Authorized Representative), Legal Manufacturer Services (Legal as a Service), EU Representative / Authorized Representative, QM Consulting (Setup of QM System according to ISO 13485 and MDR), Audit Support (Supplier, Internal Audits, Notified Body Preparation)
- Materials
- Legal as a Service, EU Authorized Representative, QM Consulting and QMB Assumption, PRRC Assumption, Regulatory Affairs Consulting
- Certificates
- ISO 13485
- Industries
- Medical Technology / Medical Devices (Ophthalmology, Anesthesia, Urology), Medical Technology / Medical Devices (including Ophthalmology, Anesthesia,
- 01
Consulting on QM setup according to ISO 13485 and MDR
- 02
Regulatory Affairs Consulting (Classification, Clinical Data, EUDAMED)
- 03
Assuming the role of Legal Manufacturer or EU Authorized Representative
- 04
Taking over responsibilities (QMB, PRRC)
- 05
Market Surveillance, Vigilance, and PMS
- 06
Archiving Technical Files
Services and Expertise
Legal as a Service
Assumption of the manufacturer role and responsibility for medical devices from approval to lifecycle management.
EU Authorized Representative
Legal representative for manufacturers from outside the EU with a contact point function for European authorities.
QM Consulting and QMB Assumption
Setup of QM systems according to ISO 13485 and MDR, audit support, and provision of qualified responsible personnel.
PRRC Assumption
Ensuring product conformity, technical documentation, and compliance with PMS and Vigilance obligations.
Regulatory Affairs Consulting
Consulting on classification, clinical data, MDR/IVDR, and launch strategy.
Locations
Eschweiler
DEHeadquarters
Inside the production
Industries
Processes & technical limits
| Processes | Tolerance | Max. part | Weight | Lot size | Materials |
|---|---|---|---|---|---|
| Legal Service (Legal Manufacturer / EU Representative)Engineering | – | – | – | – | – |
| Quality Management Consulting (QM System according to ISO 13485, Audit Support)Engineering | – | – | – | – | – |
| Regulatory Affairs Consulting (MDR, IVDR, EUDAMED, Classification, Clinical Data, Launch Strategy)Engineering | – | – | – | – | – |
| Assumption of Responsibilities (QMB, PRRC, Authorized Representative)Engineering | – | – | – | – | – |
Additional services
Quality and Certifications
bytec LM operates according to a quality management system compliant with ISO 13485 and the European Medical Device Regulations (MDR). The company is certified by TÜV Süd.
| Evidence | Eschweiler |
|---|---|
| ISO 13485 |