About Us
Our Story
Ensuring Quality and Compliance for Your Medical Devices
We are a team of experts in the medical device industry, dedicated to providing quality management and design history file support to companies producing medical devices. With a combined experience of many years in the industry, we have a deep understanding of the unique challenges and requirements of the medical device sector.
Our mission is to help our clients navigate the complex regulatory landscape, and ensure that their products meet the highest standards of quality and safety.
We offer a full suite of quality management and design history file services, including risk management, process validation, design control, and change management. Our team of experts will work closely with you to understand your needs and develop a customized solution that meets your specific requirements.
We offer a full suite of quality management and design history file services, including risk management, process validation, design control, and change management. Our team of experts will work closely with you to understand your needs and develop a customized solution that meets your specific requirements.
Our goal is to help our clients achieve regulatory compliance, reduce risk, and improve the overall quality of their products. With our support, you can be confident that your medical devices are designed, developed, and manufactured to meet the highest standards of quality and safety.
Let us help you achieve success in the medical device industry. Contact us today to learn more about how we can support your business.”
Our Values
Quality, Integrity, Expertise: Guiding Your Medical Device Success
01.
Quality
Committed to delivering high-quality services and solutions that meet the needs and expectations of clients.
02.
Integrity
Operating with honesty and transparency, and upholding ethical standards in all business practices.
03.
Expertise
Providing clients with expert advice and guidance, leveraging in-depth knowledge of the medical device industry and regulatory requirements.
04.
Customer Focus
We are the experts in our field. Therefore, it is important to have the courage to do what is right knowing that it is for the better good of the person ahead.
05.
Continuous Improvement
Committed to continuous learning and improvement, and staying at the forefront of industry developments and best practices.
06.
Safety
Committed to ensuring the safety and efficacy of medical devices, and supporting clients in achieving regulatory compliance and reducing risk.
Testimonials
What Our Clients Say
QMS and DHF support helped us streamline our processes and achieve regulatory compliance. Their expertise and commitment to quality is unmatched.
Mr. Haruki
Their personalized approach and attention to detail is what sets them apart in the industry. Highly recommend!
Miss. Anastasia
Our company has seen significant improvement since partnering with QMS and DHF support. They're the experts we trust.
Mr. Dmitry
Their team is knowledgeable, responsive, and always goes the extra mile. Highly recommended!
Miss. Emma
We couldn't have done it without the support of QMS and DHF. Their expertise and commitment to our success is unparalleled.
Mr. Nirav
QMS and DHF support has been a valuable partner in ensuring the quality of our medical devices. Their expertise has been invaluable.
Mrs. Rachel Kim
