- Experienced Third
Party Reviewer with UL
- Trained Third Party Review engineers for-Sterility, Biocompatibility, Software, test documentation validation, Documentation validation and procedures
- Worked with numerous clients in resolving technical issues to ensure FDA and Safety Compliance
- Wide area of
expertise which covers Software to Sterility issues.
- Networks with other professionals to find answers. If we don't have the answer, we will get you the right answer quickly.
- Qualified by Cameron Quality Consultants for MDD/IVDD Quality Systems
- In Depth Industry experience with IEC 61010, IEC 601950, IEC 60601-1 assisting clients getting their products certified.
- Conducted Seminars for Businesses for Software Compliance Issues
- Offices in the US and China
- Can assist US manufacturers with CCC certifications
- Have
developed Third Party Reviewer network to get your device reviewed
quickly
| |