Devine Guidance

Purchasing Controls is not Rocket Science!

By Dr. Christopher Joseph Devine

A well-balanced purchasing controls program encompasses many tools, but in an effort to meet the requirements delineated within §820.40, the FDA expects establishments to have certain elements in place.

A well-balanced purchasing controls program encompasses many tools, but in an effort to meet the requirements delineated within §820.40, the FDA expects establishments to have certain elements in place.

Continue reading

Devine Guidance

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

By Dr. Christopher Joseph Devine

If your establishment is planning to introduce a medical device into commerce, it is incumbent upon the organization to correctly classify the medical device and obtain the appropriate clearance/approval before offering the finished device for sale or advertising on your establishment’s website. Failure to do so will end badly.

If your establishment is planning to introduce a medical device into commerce, it is incumbent upon the organization to correctly classify the medical device and obtain the appropriate clearance/approval before offering the finished device for sale or advertising on your establishment’s website. Failure to do so will end badly.

Continue reading

Ameing for Asia

Who Should Hold Your Product Registrations in Asia?

By Ames Gross

Most international medical device companies work with Asian distributors to sell their products in the local marketplace. Finding, qualifying, and signing up the right distributors is an important job since these distributors will sell your products locally. Another key aspect is who holds the registration.

Most international medical device companies work with Asian distributors to sell their products in the local marketplace. Finding, qualifying, and signing up the right distributors is an important job since these distributors will sell your products locally. Another key aspect is who holds the registration.

Continue reading

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

What About the Reports?

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

If you work in the device industry in the United States and introduce FDA approved/cleared product into commerce in the United States, then it is incumbent upon the device establishment to play by FDA’s rules. Remember, if you are playing in FDA’s sandbox, then you must play by FDA’s rules.

Continue reading

Reimbursement Report

Living with a Legacy – Reimbursement Barriers Based on Technologies that Came Before

By Elizabeth Brown, MD

Prior “aggressive” tactics of manufacturers launching new technology can poison the reimbursement environment for a related, but distinct technology occupying the same space. This discussion traces the history of two of the most challenging reimbursement environments: wound healing and spine technologies.

Prior “aggressive” tactics of manufacturers launching new technology can poison the reimbursement environment for a related, but distinct technology occupying the same space. This discussion traces the history of two of the most challenging reimbursement environments: wound healing and spine technologies.

Continue reading

Ameing for Asia

Hopes and Hurdles for Medical Device Companies in China in the Year of the Ram

By Ames Gross

There are great opportunities for foreign medical device companies in China as the people want better healthcare, the government is increasing access to healthcare, and the market is growing between 15 and 20 percent per year. But access to the marketplace is harder than ever. Why?

There are great opportunities for foreign medical device companies in China as the people want better healthcare, the government is increasing access to healthcare, and the market is growing between 15 and 20 percent per year. But access to the marketplace is harder than ever. Why?

Continue reading