Regulatory
ISO 13485:2016 sets the standard for quality management systems in the design and manufacturing of medical devices. TechNH is fully compliant with ISO 13485:2016 requirements, demonstrating our commitment to the highest levels of quality and safety in medical device manufacturing. Our adherence to this standard ensures that our processes are meticulously controlled and documented, resulting in products that meet the strict regulatory requirements of the healthcare industry.
Compliance with FDA (U.S. Food and Drug Administration) regulations are essential for companies involved in the production of medical devices and healthcare products. TechNH is registered with the FDA and complies with 21 CFR 820 regulations governing medical device manufacturing. This certification underscores our dedication to meeting the regulatory requirements of the healthcare industry and delivering products that prioritize patient safety.
TechNH has been ITAR registered since 2010, and we have been supplying the defense industry for many years. We have implemented robust security measures and controls to ensure that sensitive information and technology are safeguarded throughout the manufacturing process. Our ITAR compliance underscores our dedication to maintaining the integrity and security of our clients’ projects, while also upholding national security interests.
UL certification is a mark of product safety and quality assurance. TechNH’s facilities are UL recognized, with four parts falling under the scope of UL certification. UL recognition signifies our commitment to product safety and quality assurance, providing our customers with confidence in the reliability of our products.
TechNH is committed to environmental responsibility and compliance with applicable regulations. We adhere to local, state, and federal regulations regarding waste disposal, water management, and materials standards. Additionally, we prioritize compliance with environmental directives such as REACH, RoHS, Conflict Minerals, California Prop 65, and EUMDR as required by our customers.
Our metrology lab is equipped with state-of-the-art inspection equipment, enabling us to maintain the highest levels of quality and precision. At TechNH, we understand the importance of traceability in ensuring product quality and regulatory compliance. We maintain complete traceability back to raw materials, with electronic records available in our ERP system and paper Device History Records (DHRs) retained for at least seven years. Our commitment to meticulous record-keeping and traceability ensures transparency and accountability throughout the manufacturing process.
