Consulting and technical documentation for machinery safety and medical device safety
C. R. C. Partnerschaftsgesellschaft
LübeckNew on Amplifa
About CRC
C. R. C. Partnerschaftsgesellschaft (CRC) is a consulting company based in Lübeck that supports manufacturers of machinery and medical devices with safety, regulatory compliance, and technical documentation. In the field of machinery safety, the company creates safety concepts, risk assessments, conformity assessments, operating instructions, and CE marking documentation, and performs analyses such as HAZOP and LOTO. In the field of medical device safety, the offerings include MDR and IVDR documentation, qualification and validation, manufacturing documentation, risk management, usability, vigilance systems, and maintenance of technical files. Furthermore, CRC assists with setting up quality management systems, process development, gap analyses, internal audits, and regulatory inspections. The company was founded in 1995, is organized as a partnership company, and employs a small number of staff. It has a connection to the Technical University of Lübeck.
- Site
- Lübeck
- Processes
- CE Marking of Machines (Safety Concepts, Documentation, Conformity Assessment), Risk Management and Safety Analyses (HAZOP, LOTO, Risk Assessments), Medical Device Safety Consulting (MDR/IVDR Documentation, Validation, Usability,, Setup of Quality Management Systems, Process Optimization, Internal Audits, Gap Analyses, Consulting and Technical Documentation for Machinery Safety, CE Marking (Machinery), Risk Assessments, Safety Concepts
- Materials
- Machinery Safety, Medical Device Safety, Consulting and Management Systems
- Certificates
- ISO 9001 (own certificate)
- Founded
- 1995
- Employees
- 1-10
- Industries
- Mechanical Engineering, Medical Technology, In-vitro Diagnostics, Medical Technology / Medical Devices
- 01
Inquiry and Current State Analysis
- 02
Gap Analysis against Regulatory Requirements
- 03
Safety and Risk Concepts
- 04
Creation of Technical Documentation
- 05
Support for Conformity Assessment and Audits
- 06
Support and Maintenance of Files
Services and Methods
Machinery Safety
Safety concepts, risk assessments, CE marking, operating instructions, as well as HAZOP and LOTO analyses.
Medical Device Safety
MDR/IVDR documentation, risk management, usability, validation, vigilance systems, and technical file maintenance.
Consulting and Management Systems
Setup of QM systems, process development, internal audits, and support during regulatory inspections.
Location
Lübeck
DEHeadquarters and Consulting
- Materials
- Machinery Safety, Medical Device Safety, QM Consulting
Inside the production
Industries
Processes & technical limits
| Processes | Tolerance | Max. part | Weight | Lot size | Materials |
|---|---|---|---|---|---|
| CE Marking of Machines (Safety Concepts, Documentation, Conformity Assessment)Engineering | – | – | – | – | – |
| Risk Management and Safety Analyses (HAZOP, LOTO, Risk Assessments)Engineering | – | – | – | – | – |
| Medical Device Safety Consulting (MDR/IVDR Documentation, Validation, Usability,Engineering | – | – | – | – | – |
| Setup of Quality Management Systems, Process Optimization, Internal Audits, Gap AnalysesEngineering | – | – | – | – | – |
Additional services
Reference customers
Quality and Management Systems
CRC supports manufacturers in establishing and maintaining quality management systems, as well as in internal audits and regulatory inspections. Internal certificates are not verifiable from the sources.
| Evidence | Lübeck |
|---|---|
| ISO 9001 (own certificate) |
History
- 1995
Co-founding of C. R. C. Partnerschaftsgesellschaft by Dorte Kiecksee as a partner.
- 2012
Dorte Kiecksee becomes the owner of CfRC (Consulting for regulatory affairs compliance).