What Can Apps Do For Health?

By MedTech Intelligence Staff

…order to discuss the value of their idea and obtain important advice and support. Further information is online at http://evs.curemyway.com. Information about MEDICA 2014 exhibitors, product information, company news and…

…order to discuss the value of their idea and obtain important advice and support. Further information is online at http://evs.curemyway.com. Information about MEDICA 2014 exhibitors, product information, company news and…

Continue reading

Dr. Christopher Joseph Devine, President, Devine Guidance International
Devine Guidance

Manufacturers of Class I and Class II Exempt Devices Still Require a QMS

By Dr. Christopher Joseph Devine

…21 CFR, Part 820.20(e)” bad news is about to be dropped into the lap of an offending establishment’s chief Jailable officer (CJO), if they have one. Otherwise, the CEO is…

…21 CFR, Part 820.20(e)” bad news is about to be dropped into the lap of an offending establishment’s chief Jailable officer (CJO), if they have one. Otherwise, the CEO is…

Continue reading

Top 10 Reasons for FDA Warning Letters to Medical Device Firms

By Chris Celeste

…Services Division, including, supervising the research associates and the weekly publication of the “FDA News & Information.” He has a Regulatory Affairs Certification (RAC) from the Regulatory Affairs Professionals Society….

…Services Division, including, supervising the research associates and the weekly publication of the “FDA News & Information.” He has a Regulatory Affairs Certification (RAC) from the Regulatory Affairs Professionals Society….

Continue reading

Dr. Christopher Joseph Devine, President, Devine Guidance International
Devine Guidance

Part Three – Production Controls “What’s the Point?”

By Dr. Christopher Joseph Devine

…changes shall be validated before approval and issuance. These validation activities and results shall be documented. Compliance for Dummies The good news is that production and process control is not…

…changes shall be validated before approval and issuance. These validation activities and results shall be documented. Compliance for Dummies The good news is that production and process control is not…

Continue reading

Dr. Christopher Joseph Devine, President, Devine Guidance International
Devine Guidance

Failure to Establish and Maintain

By Dr. Christopher Joseph Devine

…483 observation. Finally, the good news is that FDA does not retain the authority to review the results of your organization’s supplier audits. However, device establishments must provide objective evidence…

…483 observation. Finally, the good news is that FDA does not retain the authority to review the results of your organization’s supplier audits. However, device establishments must provide objective evidence…

Continue reading

CAPA Corner

CAPA Corner: The Case of the Defunct TV

By Tom Weaver

…going well as I was greeted with the news that our television was not working! Now this television was only a month old. We had gone out one beautiful spring…

…going well as I was greeted with the news that our television was not working! Now this television was only a month old. We had gone out one beautiful spring…

Continue reading

Dr. Christopher Joseph Devine, President, Devine Guidance International
Devine Guidance

Use Complaints to Fix Problems!

By Dr. Christopher Joseph Devine

…in the medical device karma bank. Otherwise, rest assured your competitors will be knocking on your customer’s door informing them of the great news; “guess who just got a warning…

…in the medical device karma bank. Otherwise, rest assured your competitors will be knocking on your customer’s door informing them of the great news; “guess who just got a warning…

Continue reading

Worldwide Medical Device Regulatory Updates

By Stewart Eisenhart

…Group, where he publishes news and analysis regularly on the firm’s QA/RA blog covering medical device industry and regulatory developments in markets worldwide. He has 15 years of experience writing…

…Group, where he publishes news and analysis regularly on the firm’s QA/RA blog covering medical device industry and regulatory developments in markets worldwide. He has 15 years of experience writing…

Continue reading

Dr. Christopher Joseph Devine, President, Devine Guidance International
Devine Guidance

Finally, eMDRs

By Dr. Christopher Joseph Devine

…enter MDR data into the program. The good news is that program aligns with 21 CFR, Part 803 so the user should always be able to enter the required data;…

…enter MDR data into the program. The good news is that program aligns with 21 CFR, Part 803 so the user should always be able to enter the required data;…

Continue reading