Cookies ensure the proper functioning of our website. By continuing your navigation, you accept their use.Learn moreI accept

Medical Devices

Engineering

Equipements processes and utilities

From URS to qualification & launch and operation

Technical study on phases of Concept Engineering - Basic Engineering - Detail Engineering:

  • Processes
  • Mechanics
  • Electricity / Automation (GAMP5) / Instrumentation
  • HVAC

Commissioning:

  • Installation tracking
  • Protocol Execution
  • Troubleshooting

Production Support and Continuous Improvement

R & D

Medical devices R&D

Our expertise covers the main types of medical devices:

  • HardWare Engineering: Mechanical, Electronic
  • SoftWare Engineering
  • System Engineering
  • Design Control (820.30) and Design & Development (ISO13485)
  • Risk management (ISO 14971)
  • Human factors : fitness for use (ISO 62366)
  • Verification & Validation
  • Industrialization

Our skills:

  • Combined product
  • Diagnostic device
  • Implantable medical devices (active or passive)

Qualification / validation

Equipment processes and utilities

  • Qualification of equipment or utilities:
    • risk analysis (FMECA)
    • DQ / IQ / OQ / PQ protocols writing
    • protocol executions
    • report writing
  • Process validations
  • Cleaning and sterilization validation (CIP / SIP / COP)
  • Computerized systems validation (CSV)

Quality support R&D or production

  • Quality Management System according to ISO 13485 / FDA and Group Directives
  • Quality Assurance (QA):
    • Operational QA: CAPA, deviation, change control, batch records review, investigations...
    • Supplier QA
    • Compliance
    • Review and approval of protocols for qualification and validation
    • Quality Engineering
  • Quality Control (QC):
    • Development / Validation / Transfer of analytical methods and physicochemical tests
    • Biocompatibility issue
    • Laboratory equipment qualification according to GMP or ISO 13485

Regulated environment: ISO 13485, ISO 14971, ISO 62366, 21 CFR Part 820 ...

Regulatory Affairs :

  • Knowledge and control of the technical and regulatory aspects of DMs
  • Monitoring of normative and regulatory developments
  • Demonstration of conformity according to the directives 93/42 / EEC (MD) and 98/79 / EEC (IVD MD) and regulations 2017/745 (DMMD 2017/746 (IVD MD) and / or FDA and others (MDSAP, CFDA) en vigor
  • Management of accreditation to be present on a market (registration and maintenance of CE marking, 510K, etc.).

Post-market surveillance:

  • Materiovigilance,
  • Surveillance of client and clinical returns,
  • Monitoring of maintenance returns,
  • Supervision of communications by competent authorities and arrangements for competition.
  • Implementation and follow-up of the necessary actions (corrective maintenance, withdrawal from the market, information to the competent authorities ...)

  • Project management Engineering: new works or revamping
    • Infrastructures & buildings
    • Utilities (EPU, EPPI, steam ...)
    • Equipment (formulation, filling, assembly, UDI marking)
  • Construction phase: technical coordination and follow-up
  • R & D project management: product development according to Design Controls
  • Device Engineering : technical coordination of product development
  • Risk Management according to ISO 14971
  • Transfer of technology, production or outsourcing / outsourcing to CMO .
  • Quality project management: audit preparation, upgrading of an ISO13485 quality system
  • Family purchase: support for Outsourcing for development with CMOs

We have 8 positions to be filled

Find your place!

Join the tribe !