TJS Technical Services Inc. services for global medical device approvals include the following:
- Concept Phase, identification of potential challenges and opportunities
- Requirements Documentation
- Design Consultation with customer engineering staff throughout the development phase
- Documentation and Labeling guidance
- Risk Management/Assessment guidance and evaluation (ISO 14971, IEC/EN 60601-1)
- Approvals Documentation Package - Preparation of documentation required by the approvals agencies
- Product Safety guidance and coordination of testing and approvals (IEC/EN/UL 60601-1 and Part 2 product specific standards)
- Electromagnetic Compatibility (EMC) guidance and coordination of testing and approvals (IEC/EN 60601-1-2)
- Negotiating standards interpretations with testing and approvals agencies
- Reliability - Design (Best Practices), Analysis (FMEA/FTA), Availability, Maintainability, HALT/HASS, MTBF/MTTR using Mil-HDBK-338B, Mil-HDBK-781, Mil-HDBK-217.
- International Approvals (i.e. US, Canadian and International Approvals coordination, EU Directive such as RED, LVD and EMCD)
- Environmental Regulations (i.e. European Union WEEE, RoHS, Battery Recycling Requirements)
- Radio / Intentional radiator requirements and approvals
- Product Integrity Requirements (IP/NEMA Water and Dust Ingress, Thermal/humidity, Vibration and shock/drop, NEBS, etc.)
Regardless of where you are in the development or life-cycle of your medical device, contact us to discuss how we may be able to provide value and support your efforts.
TJS Technical Services Inc.
