Project Office Manager
The EN ISO 13485 standard and FDA CFR Title 21, Part 820 require a systematic development process with clearly defined phases and corresponding approvals as well as adequate preparation of required documents.
Our services:
Helping to establish a systematic development process
Participating in the creation of the project plan and the document plan
Ensuring a structured approach
Providing necessary document templates
Timely initiation of cross-phase activities such as
- risk management
- usability engineering
- software life cycle processes
Timely evaluation and approval of important suppliers
Timely integration of the industrialization team
Your benefit:
Establishment of a standard-compliant development process
Increasing safety in product development
