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MAKCOMPLIANCE.COM

MAK and Associates, LLC

Knowledge fosters voluntary participation

http://www.makcompliance.com/

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STEVE KRUEGER

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ST●●●●●●●●●●●●●●●●@YAHOO.COM

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Knowledge fosters voluntary participation
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MAK and Associates, LLC | makcompliance.com Reviews

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1

FDA Webinar: Distinguishing Medical Device Recalls from Medical Device Enhancements – Final Guidance – MAK and Associates, LLC

http://www.makcompliance.com/archives/116

MAK and Associates, LLC. Knowledge fosters voluntary participation. Our Mission and History. FDA Webinar: Distinguishing Medical Device Recalls from Medical Device Enhancements Final Guidance. November 3, 2014. 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. http:/ www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/ucm419121.htm. November 5, 2014. Get solutions to your regulato...

2

Quality System Assessment Promotion – MAK and Associates, LLC

http://www.makcompliance.com/archives/87

MAK and Associates, LLC. Knowledge fosters voluntary participation. Our Mission and History. Quality System Assessment Promotion. October 27, 2014. 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,. 169; 2016 Home.

3

Industry News – MAK and Associates, LLC

http://www.makcompliance.com/archives/category/idnews

MAK and Associates, LLC. Knowledge fosters voluntary participation. Our Mission and History. FDA Webinar: Distinguishing Medical Device Recalls from Medical Device Enhancements Final Guidance. November 3, 2014. 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. http:/ www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/ucm419121.htm. Book an Into Call. Subscribe to Blog via Email.

4

Creating a medical device regulatory strategy document – MAK and Associates, LLC

http://www.makcompliance.com/archives/84

MAK and Associates, LLC. Knowledge fosters voluntary participation. Our Mission and History. Creating a medical device regulatory strategy document. October 27, 2014. 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. How to establish your company quality system. Leave a Reply Cancel reply.

5

About Us – MAK and Associates, LLC

http://www.makcompliance.com/home/about

MAK and Associates, LLC. Knowledge fosters voluntary participation. Our Mission and History. MAK and Associates is a group of successful regulatory, quality, and engineering professionals. We have solved many regulatory compliance problems applying our expertise, resources, and tool sets. We will put your anxiety to rest. Steve works with Medical Device and Health Information Technology companies to establish and maintain a path to regulatory compliance which enables … Read more. Book an Into Call.

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MAK and Associates, LLC. Our Mission and History. Finding our website is your first step to help with your regulatory compliance issue. MAK and Associates, LLC provides value and solutions to small to medium size Medical Device Manufacturers, Medical Device Importers, and Healthcare organizations. You have little understanding of regulatory issues or the ramifications if there are problems. You cannot afford a staff person for regulatory and quality. Regulatory and Quality Strategy and Planning.

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