Regulatory Compliance
Farm is an FDA and ISO compliant product development company offering comprehensive development services under strict FDA design controls.
Farm complies with the process and documentation controls required for Specification Developers under the Quality System Regulations of Section 21 of the Code of Federal Regulations Part 820 and International Standards Organization 9001/2000 & 13485/2003. As a Specification Developer, Farm creates elements for Design History Files and Device Master Records following our clients' or Farm's own Quality System Standard Operating Procedures.
Farm also creates prototypes for evaluation and conducts usability tests throughout the stages of development. This leads us reliably to a high-quality ergonomic design and provides our customers with important components of good human factors for a Design History File. At Farm, we welcome audits of our Quality System by quality representatives of our customers and prospects.
Regulatory Compliance Services
Farm generates:
- Design plans
- Design inputs
- Risk analyses
- Formal design reviews
- Drawings and specifications
- Verification and validation
- Work instructions
- Labeling
- Change control
- Design transfer