Medical Device Quality Consulting in Asia

Medical companies in Asia are often challenged by complicated changes in market dynamics and regulatory demands. Keeping up with these ever-changing regulations in Asia and other unique aspects of the Asia market requires years of experience, vigilance, and constant education.

This is where Vicki Partridge Pty Ltd comes in. With more than 30 years of experience in the regulatory affairs industry, we can be of great help in all stages or aspects of your medical device business, from market research, product registration, regulatory strategy, and medical device consulting.​​

The entire regulatory process from product design to marketing of a new medical device is often unclear and complicated. And if your target market is Asia, things can become more difficult, especially when it comes to creating a regulatory strategy and a business strategy.

Vicki Partridge’s medical device regulatory consulting services and robust knowledge of the Asian medical device regulations have helped a number of clients eliminate risks and uncertainties in the process. We work closely with all our clients to help them solve regulatory problems in different areas, such as product registration, quality compliance, clinical trials, and representation.

It is imperative for a medical device company in Asia to have an appropriate Quality Management System. With a QMS, companies can perform to the highest standards and eliminate product imperfections and faults, especially when they are operating in low-cost Asian countries like Vietnam, India, and China. In more advanced countries like Japan and Korea, Quality Management Systems and medical device registration requirements are more complicated.

Vicki Partridge’s team possesses skills and all the required quality certifications to help your medical device company in installing and maintaining Quality Management Systems.

Vicki Partridge’s medical device quality consulting service can help you get insights on Asia’s booming medical device industry. Our team of expert consultants has already assisted and worked with international clients for medical device classification, registration, and reimbursement.

We also specialize in complex projects that need innovative strategic thinking and deep industry understanding. We possess the expertise and skills to help companies penetrate and succeed in the Asian medical markets.

Services we offer include:

• Compliance Consulting;
• Regulatory Approval;
• Training Workshops;
• Pre-Audit Assessments;
• Quality Audits;
• Acting as Product Sponsor;
• Clinical Trials; and
• Prosthesis List.