SW Validation
Our team of senior SW consultants can assist you to achieve compliance in combination with higher productivity in your software development organization.
We offer the following consulting services:
- Write,
review, adjust for software departments
- Standard Operating Procedures
- Work Instructions
- Guidelines and checklists
- Auditing of
software departments
- QSR and Part-11
- 14971,62304, 62366
- Training
- QSR
and ISO 13485
- Software
risk management, software engineering, agile methods
- Independent review
- Product
safety strategy
- Risk
Management File
- Technical
File
- Project manager
- Product
development
- Compliance
improvements
- Validation of software
for regulated processes
- Administrative
software
- Research
and development
- Manufacturing
- Maintenance
- Support during FDA-audits
- Preparations
- Back-office
support during audits
- Follow-up
activities
- Iterative methods
- Agile
- Lean
- Integration
Centric Development
- Tool
support
- Application of risk
management to information technology (IT) networks incorporating medical
devices