IEC 60601-1, 3rd ed. – How to Manage the Certification & Regulatory Risk. Consulting Group
“Trying to pass a safety certification without preparation is like trying to pass a calculus class without studying for the final exam.”
Today, introducing a new product to market is a risky business. With ever shrinking design cycles, time to market becomes increasingly important and stressful. The effects of ignoring product certifications until the last minute can be devastating to your product release time and life cycle.
Let G&M’s consulting team help you prepare for regulatory compliance certification. The key to a smooth certification process is having compliant equipment accompanied by proper documentation prior to submittal. If you are unsure whether your component documentation is adequate or if the construction design of your product will meet certification requirements, we recommend a pre-certification evaluation.
G&M has key experts in the areas of Product Safety, EMC/EMI, Medical, Machinery and International compliance. We can custom tailor consulting projects using our experts in key areas based on your company’s specific needs.
The Key Areas of Expertise Include
- Agency Assistance & Certification
- Developing Test Plans and Procedures
- Electromagnetic Compatibility Design Guidance and Evaluation
- Product Safety Design Guidance and Evaluation
- Product Testing
- Risk Analysis
- Troubleshooting and Retrofitting
- International Certifications Requirements
- Medical IEC 60601-1, 3rd Edition Preparation, Gap Analysis and Pre-Evaluation
- Working with Sales/Marketing, Management and Engineering Department to Generate a Global Certification Plan
- China Certification (CCC and SRRC)