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The FDA is putting on a Webinar to go over and answer questions related to the final guidance on Distinguishing Medical Device Recalls from Medical Device Enhancements.

Continue reading FDA Webinar: Distinguishing Medical Device Recalls from Medical Device Enhancements – Final Guidance

November is Quality System month here at MAK and Associates, LLC. and we are proud to introduce our Quality System Assessment Promotion. We are offering a no cost, no obligation introductory call to discuss your quality system assessment. Depending on the scope, your assessment may include: Review of your current quality system documentation, Evaluation opinion …

Continue reading Quality System Assessment Promotion

Clients ask me what they need to do to market their medical device in different countries. Often times a company will have a sales lead in a new country or a business plan to take them there, but they are unsure of all the quality and regulatory steps to get them there. The initial step …

Continue reading Creating a medical device regulatory strategy document

Much like a business plan, a company’s regulatory strategy sets a plan in action to market medical device products in specific countries. The regulatory strategy details a description and intended use for each of the company’s products, identifies the countries where each of the products will be marketed, records the device classification decision, and develops …

Continue reading Setting your regulatory strategy