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Regulatory Services - ISO 13485
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KEMA Registered Quality, Inc.
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You manufacture innovative medical devices and you want to get these products to different markets quickly. Interactive cooperation with your Notified Body would facilitate your understanding throughout the whole regulatory process. Wouldn't it be convenient to work with an expert Notified Body who has knowledge of your product while recognizing your needs for time to market? Special expedited programs are available to decrease the time to market for your products. KEMA offers one-stop-shopping for the key medical markets in the EU, USA, Canada, Japan, Taiwan, and Australia. KEMA knows the medical device world better than most. With our model of dedicated project management, responsibilities are clear and you get a dedicated KEMA contact.
Rapid time to market
Getting a medical device to market is a long process. Extended in-vitro verification testing, animal studies, and clinical evaluations take much time and money. On top of that, regulatory approval is needed. KEMA focuses on minimizing the complexities of the regulatory process that allows for a shorter and smoother approval process. Where time to market is of the essence, we offer expedited review and certification routes. Reviewing the clinical protocol or parts of submissions in a modular approach early on, can reduce time pressure at the end of the process.
Flexible business solutions
Our project managers have a background in the medical device industry, mostly in R&D and/or manufacturing. Many of them hold advanced degrees, e.g., Ph.D. or MBA. They understand the challenges of a medical device manufacturer, are dedicated to sharing their experience, and to discuss solutions for compliance problems. Our goal is to seek consensus on solutions while maintaining a focus on compliance. Explaining different labeling options, contacting the drug authorities to get a reasonable review time are things we do on a daily basis. Are you looking for a new Notified Body to take care of your existing certificates and reports? We are ready to serve you with a special uncomplicated Transfer of Certification Program.
Your own multi-service project manager
At KEMA the customer gets a dedicated project manager, who is your contact person for all KEMA services. He or she is responsible to answer your questions, arrange and participate in audits, assure competent reviews of your submissions, and provide quotations for additional services. He or she knows your company, your market, your clients, your quality system, and your devices. He or she connects to your specific problems and helps finding solutions. The KEMA project manager is usually local, but may use the resources of our global network of medical device experts to meet your needs.
Continuous investment in knowledge
KEMA is a leading Notified Body and Third Party Representative that continuously invests in knowledge. We provide training and seminars . We speak at conferences and participate actively in regulatory meetings in Brussels and throughout the world. Internally, our global project management staff harmonizes its knowledge with trainings at our headquarters every year. All of our auditors participate in annual training, and they exchange experience semi-annually. We actively track new developments in regulations and technology to ensure our project managers have the most up-to-date knowledge. KEMA's outstanding medical specialist network participates in our clinical reviews. We specialize in key high-risk and innovative areas such as drug/device combinations, devices incorporating animal tissue, laser, and nuclear therapy
Global presence
KEMA's strategy is based on having local presence in the major medical device markets around the world. Our aim is to have a local office with full operational staff to support your approval needs, even for the highest-class devices.
One-stop-shopping
The one-stop-shopping concept is essential for manufacturers exporting their product to international markets. KEMA's strategy is aimed at providing all possible market access services. More and more governments worldwide are defining a role for Third Party approval in their national regulations. We keep investing in new accreditations.
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