Medical Device Compliance and Regulatory
TJS Technical Services Inc.
TJS Technical Services Inc. has a team of experienced professionals knowledgeable with a wide range of medical device approvals requirements and processes. We are also experienced in preparing risk analysis documentation required by the product safety testing and approvals agencies prior to the formal assessment.
TJS Technical Services Inc. services for global medical device approvals include the following:
Concept Phase, identification of potential challenges and opportunities
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, Reliability Demonstration Testing, HALT/HASS, MTBF/MTTR using Mil-HDBK-338B, Mil-HDBK-781, GMW8287, Mil-HDBK-217, Telcordia TR-332/SR-332.
International Approvals (i.e. US, Canadian and International Approvals coordination, EU Directive such as R&TTE, 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.