Production, QHSES & Compliance
Quality – QMS Medical Devices
Project
- Management of the quality manual and the Master File site
- Management of quality documents (drafting, review and archiving): policy, processes, procedures, templates and instructions based on the activity carried out
- Staff training on documents
- Training for internal, external and inspection audits
- Management of non-compliance / anomalies / incidents / deviations, CAPA and complaints
- Management reviews/product quality/quality approval
- Change and risk management
Project Duration
12
months
Expertise
- SMQ
- ISO 13 485
- Biotechnology industries
- DM manufacturers
Challenges
- Quality : 4/5
- Cost : 2/5
- Deadlines : 3/5
- Security : 5/5
Services provided
- Services provided
- Preliminary design (studies, planning)
- Writing and updating of documents
- Exchange control, claims and CAPA management
- Product control
- Process/product risk analysis
- Support in implementing and monitoring indicators
- Veille Regulatory watch
Insight
What it means to be a Fortil associate?
Accessing to the capital of an independent Group, solidly profitable for 15 years, with no debt and no outside financial investors. Unique in Europe of its size: 2,000 employees. Today, 250 associates hold 100% of the capital.
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Numtech, a leader in environmental issues for 22 years, works on more than 3,000 projects in 40 countries, supporting you on your impact issues thanks to an environmental footprint diagnosis (EED).
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Numtech, an innovative and committed company for 20 years, is now part of the Fortil group
Numtech has been committed to protecting ecosystems for over twenty years and operates worldwide.
Insight, Testimony
Ugo Mola, sponsor of Fortil endowment fund
Ugo Mola, sponsor of Fortil endowment fund
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Fortil acquires the CNIM group’s Information Systems Department
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Our teams are working to expand a model focused on expertise and sustainability.
