 |
|
|
|
|
|
|
|
|
Get Your Medical Device to Market Faster In the highly-regulated medical device industry, reaching your local or global target markets quickly and cost-effectively is a tough task. At times, it seems as if compliance requirements change on a daily basis.
Intertek provides you with the industry-specific expertise you need to gain global market access and maximize revenue potential. From design review to final testing and beyond, our solutions can help you ensure that you are introducing your products according to your schedule: - Medical device safety testing, evaluation, and certification, to standards such as IEC 60601-1 and the CB Scheme
- Regulatory services such as FDA 510(k) third-party reviews, Notified Body assessments for CE Marking, and Accredited Person (AP) inspections
- Management systems certification to standards such as ISO 13485, ISO 14971, and ISO 9001
- Electromagnetic compatibility (EMC) testing for electrical medical devices
- Product testing and certification for RoHS compliance
- Performance testing and benchmarking
Whatever your target market, Intertek’s global network of experts is ready to help you reach it. To get started, call us at 1-800-WORLDLAB (1-800-967-5352) or send an email to icenter@intertek.com.
|
|
|
|
|
|
|
|
|
|
|
Are you up-to-date on the latest requirements?
|
|
|
In the ever-changing medical industry, it is critical that you stay informed on the requirements that may affect your product and its market entry. Learn how to navigate some of the industry’s toughest regulations by watching Intertek’s webinars.
Register to view any or all of these webinars online at your convenience.
|
|
|
|
Planning Tool
|
|
|
Our FDA 510(k) Resource Guide provides tools you can use to simplify the submission process, such as an Eligible Device Quick Reference Guide and links to FDA resources. Download your free copy.
|
|
|
|
|
|
|
|
|
|
|
