→ Projects management for product development in the specific environment of the medical devices. Anticipation and control of hazards and risks, in the regulatory field of the MD. Project launch. Cross-functional and / or offshore team management. Internal or supplier negotiation. Communication to stakeholders. Project closure and capitalization. Compliance with ISO13485 requirements.
→ Support for the complete development cycle: definition of specifications and user needs, functional analysis, risk analysis, CAD design, prototypes, etc. Whatever the stage of development of your device (pre-study, phase 1, 2 or 3 clinical trials), we can help you.
- Definition of user needs (URS)
- Functional analysis
- Requirements redaction
- Pre-study (market analysis, patents, etc.)
- Proposal of technical, regulatory and normative solutions
- Risk analysis
- Medical devices CAD design
- Medical device verification protocols redaction
- Realization of V&V tests
- Qualification of manufacturing tools (injection, US welding, etc.)
→ Identification and description of all business processes, internal and external customer / supplier relationships, human and material resources and the information system. The processes or activities can be operational (those that the customer buys), management processes (company strategy and policy), support processes (human and material resources). We can assist in the drafting of all the documentation associated with the processes and records (controls) to be systematized, in the establishment of document management, and in the definition and formalization of the strategy and objectives.
- Implementation / Compliance of Quality Management System (GMP, CFR part 820, ISO 13485), redaction of the Quality Manual.
- Validation of special processes (packaging, ETO sterilization, gamma, etc.)
- Validation of biocompatibility (tests according to ISO 10993, Drafting of BRA, etc.)
- Equipment qualification / validation (packaging, cleaning, sterilization), Computerized systems
- Internal audits and subcontractors
→ Compliance with the regulations on medical devices 2017/745. Establishment of regulatory compliance (gather evidence demonstrating that the device is safe and effective). Determination of expected use. The intended use determines the class of the device and the strategy to be followed to demonstrate its compliance. Construction of the technical file gathering the proofs of compliance: design, risk management, validations of special processes, biological evaluation, clinical evaluation, post production and post market surveillance (PMS) monitoring, etc.
- Support for the creation of CE marking files (Regulation 2017/745)
- Update of DHF / Product File
→ Evolution of standards, of the regulatory framework, evolution within your organization itself ... Change is essential to any entity, and it is valid for people as well as for companies. Without change, there is no adaptation ... Change is therefore fundamental, and also complex, as organizations, its members and ecosystems are increasingly complex. If you don't take this complexity into account, you risk failure. How many times have we tried to make a difference and found ourselves facing resistance? We can support you in leading the change.