Medical Devices in Canada: How to Enter the Market

By MedTech Intelligence Staff

As much of the focus surrounding medical device regulation involves FDA and EU requirements, the regulations in Canada can be misunderstood. Although the degree of difficulty in regulatory approval varies…

As much of the focus surrounding medical device regulation involves FDA and EU requirements, the regulations in Canada can be misunderstood. Although the degree of difficulty in regulatory approval varies…

Continue reading

Devine Guidance

FDA Issues a Warning Letter with no Plant Inspection! What?

By Dr. Christopher Joseph Devine

…complaint management, recalls, MDR, etc.). Dr. D always recommends to my clients to just bite the bullet and implement a Quality Management System that is in compliance with 21 CFR,…

…complaint management, recalls, MDR, etc.). Dr. D always recommends to my clients to just bite the bullet and implement a Quality Management System that is in compliance with 21 CFR,…

Continue reading

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

No Established Procedure for Servicing will Result in a Form 483 Observation!

By Dr. Christopher Joseph Devine

…fix the problem. Simply stated by FDA, if the determination is that an event is reportable as an MDR, then the device establishment better make darn sure a complaint investigation…

…fix the problem. Simply stated by FDA, if the determination is that an event is reportable as an MDR, then the device establishment better make darn sure a complaint investigation…

Continue reading

Making the News for All the Wrong Reasons

…manufactured, imported or used properly. FDA is working hard to ensure the safety of consumers. In fact, the Medical Device Reporting (MDR) regulation (21 CFR 803) contains mandatory requirements for…

…manufactured, imported or used properly. FDA is working hard to ensure the safety of consumers. In fact, the Medical Device Reporting (MDR) regulation (21 CFR 803) contains mandatory requirements for…

Continue reading

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

If an Activity or Event is not “Documented” in Writing, in the Eyes of FDA, it Didn’t Happen!

By Dr. Christopher Joseph Devine

…organization ascertain if a service call may actually be a complaint that must be reported as an MDR (in accordance with Part 803) if information relating to service calls is…

…organization ascertain if a service call may actually be a complaint that must be reported as an MDR (in accordance with Part 803) if information relating to service calls is…

Continue reading

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

A Misbranded Bed; is that Even Possible?

By Dr. Christopher Joseph Devine

…limited to: Failure to adequately develop, maintain and implement written MDR procedures, as required by 21 CFR 803.17. For example, after reviewing your firm’s MDR procedure titled “QP-21-01-AH, Global Adverse…

…limited to: Failure to adequately develop, maintain and implement written MDR procedures, as required by 21 CFR 803.17. For example, after reviewing your firm’s MDR procedure titled “QP-21-01-AH, Global Adverse…

Continue reading

What Changes Should Manufacturers Expect From FDA?

…through. They are starting to look more at product quality and performing risk-based inspections based on the data than they have through MDR’s, complaints, and CAPA. Electronic audits are also…

…through. They are starting to look more at product quality and performing risk-based inspections based on the data than they have through MDR’s, complaints, and CAPA. Electronic audits are also…

Continue reading

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

Use Complaints to Fix Problems!

By Dr. Christopher Joseph Devine

…Moreover, regardless of whether a complaint will warrant a MDR, all complaints must be “INVESTIGATED” as in determining the root cause of the problem the resulted in a complaint. If…

…Moreover, regardless of whether a complaint will warrant a MDR, all complaints must be “INVESTIGATED” as in determining the root cause of the problem the resulted in a complaint. If…

Continue reading

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

Failing to File MDRs will Result in a Warning Letter

By Dr. Christopher Joseph Devine

…written MDR procedures, as required by 21 CFR 803.17. For example, after reviewing your firm’s MDR procedure titled: MDR Procedure titled U.S. Medical Device Reporting, SOP-300024 Rev: 06 and Flow…

…written MDR procedures, as required by 21 CFR 803.17. For example, after reviewing your firm’s MDR procedure titled: MDR Procedure titled U.S. Medical Device Reporting, SOP-300024 Rev: 06 and Flow…

Continue reading

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

Finally, eMDRs

By Dr. Christopher Joseph Devine

…individual MDRs or batches of MDRs. Note: It is Dr. D’s opinion; depending on the size of the batched of MDRs, this option may quickly garner agency attention. Additionally, FDA…

…individual MDRs or batches of MDRs. Note: It is Dr. D’s opinion; depending on the size of the batched of MDRs, this option may quickly garner agency attention. Additionally, FDA…

Continue reading