CISTEO MEDICAL

Minitab, Solidworks

Know-how(s)

• Regulatory Affairs
• Assembly in controlled atmosphere
• Medical device design office
• Design of connected medical devices
• Design of implantable medical devices
• Design of non implantable medical devices
• Design and manufacture of electronic cards
• Design and manufacturing of medical devices (class 2)
• Design and manufacturing of medical devices (class 3)
• Design and manufacturing of connected medical devices
• Advice on certification
• Consulting in homologation (CE marking)
• Degreasing / Cleaning / Washing / (clean room)
• Feasibility studies
• Studies and development of test bench
• Metallographic examination and chemical analysis
• Manufacturing of medical devices (class 1)
• Manufacturing of medical devices (class 2)
• Manufacturing of medical devices (class 3)
• Manufacturing of connected medical devices
• Manufacturing of medical devices (ISO 5 room)
• Manufacturing of medical devices (ISO 7 room)
• Manufacturing of implantable medical devices
• Manufacturing of non implantable medical devices
• Industrialization of assembly processes by welding techniques
• Silicone injection
• Laser (welding)
• Micro-assembly
• High precision micro-injection
• Nitinol shaping
• Prototypes (medical devices)
• Qualification of manufacturing processes
• High frequency welding
• Resistance welding
• Welding under qualification

Destination industries

• Biomedical
• Medical
• Health

Specialised in development and manufacture under contract of medical devices, Cisteo MEDICAL can assist you in every stage of your projects : from the first proof of concept to manufacturing (www.cisteomedical.com). Cisteo CONSULTING help you to create and implement your quality management system in compliance with ISO 13485 and/or 21 CFR part 820 and/or RIM. Our team can assist you in drafting and/or updating your regulatory files for European markets (EU Regulations 2017/745 and 2017/746) and also US, Canadian, Brazilian markets, etc. (www. cisteoconsulting.com).