At Hermon Laboratories, we offer a comprehensive range of medical device consultancy services provided by a dedicated and knowledgeable team committed to meeting your specific needs.

QA/RA

Our expert quality assurance professionals oversee all necessary QA operations in compliance with ISO 13485/9001 standards. We ensure that your product adheres to relevant regulations and obtains the required regulatory clearances. Our medical device consultancy services also extend to supporting and overseeing clinical trials, as well as managing submissions to regulatory bodies such as MDR, FDA, MDSP, NMPA, Russia, and more.

Quality Assurance and Regulatory Affairs Support:

At HERMON Laboratories, we possess extensive knowledge and experience to help you become more agile, cost-efficient, and expedient in product registration. We offer guidance on quality and regulatory compliance, help in managing your quality system and regulatory activities, and provide support in building a new quality system while assisting with global regulatory registration. Our global presence caters to both established global clients and startups in the medical device industry. With over 20 years of experience in medical device consultancy and regulatory registration, we have worked with a wide range of medical products across different classification levels, including Class I to Class III and implantable products.

Our Capabilities: 

• We can assist you in building and managing a Quality Assurance system in accordance with FDA 820 QSR, ISO 13485/9001, MDSP, and compliance with the new Medical Device Regulation MDR 2017_745.

• We have extensive experience in performing regulatory submissions for CE, MDSP, FDA, Health Canada, China, Russia and CIS, Latin America, Australia, Japan, and emerging markets. Our strong relationships with various laboratories and government offices worldwide enable efficient and timely product registration.

• By engaging HERMON Laboratories for medical device consultancy, we can support the creation of your Technical File, encompassing various sub-processes, including quality management system development, post-market surveillance, clinical evaluation planning and reporting, manufacturing transfer and quality engineering, validation and usability, and R&D support from product design to production.

With our team’s in-depth knowledge of medical device consultancy, we help our customers achieve cost efficiency and agility throughout the product lifecycle.