Resolution Supports Client's 510(k) Submission for Class II Medical Device

Resolution Development Services

Resolution Development Services Inc., a leading provider of product development services to the medical, life science and consumer markets, today announced the completion of the 510(k) pre-market submission for FDA review by a class II medical device customer for their next generation device.

Resolution played an instrumental role in the process to reach the submission stage.  Over a two year period, Resolution worked closely to not only develop the product but to also develop the comprehensive medical device documentation for the product needed as part of the regulatory submission.  This includes steps such as passing 60601 emissions and safety testing.

“We are pleased to see that this customer has taken the next step in their process”, said Leo Carayannopoulos, CEO of Resolution Development Services. “It is these types of complex, medical device projects where Resolution is truly able to show our breadth of capabilities and deep regulatory knowledge.”

Class II medical devices require stringent adherence to regulatory standards.  The product development process requires total coordination between development and documentation to reach the submission stage.  To learn more about 510(k) Clearances, visit the FDA website at www.fda.gov.

About Resolution Development Services:

With offices just outside of Boston, Resolution Development Services provides best in class hardware, software, mechanical, machine vision, and systems engineering outsourced services to clients in the United States, Canada, and Asia. Our regulatory compliant quality system makes Resolution the best choice for complex development programs.

To learn more about Resolution Development Services offerings, our charitable giving, and other partnerships, visit www.resolutiondev.com.

Contact:

Leo Carayannopoulos
leo@resolutiondev.com

Source: Resolution Development Services, Inc.


Categories: Healthcare Technology, Diagnostics

Tags: Medical Device, Regulatory Submission, Resolution Development


About Resolution Development

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With offices just outside of Boston, Resolution Development Services provides best in class hardware, software, mechanical, machine vision, and systems engineering outsourced services to clients in the United States, Canada, and Asia.

DJ Caruso
Resolution Development
Resolution Development
500 West Cummings Park (4050)
Woburn, MA 01801
United States