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Regulatory Updates

risk management

Sorry, I forgot to include the link.. http://www.cfpa.com/CourseDescription/CourseDescription/1607-901L/2724 [risk management] Jack Slovick President Methodize Inc P.O. Box 463 Nevis, MN 56467 763.639.0238 (cell)...

ISO 14971:2012 revisions

Jack Slovick will be conducting a webinar on the various revision changes to ISO 14971:2012 (per Annex Z,a for medical devices- the deviations), Notified Body interpretations and offering how to revamp your old files up to the new revision [risk management] Jack...

CYBERSECURITY FOR MEDICAL DEVICES

Cybersecurity for Medical Devices A growing number of medical devices are designed to be networked to facilitate patient care. Networked medical devices, like other networked computer systems, incorporate software that may be vulnerable to cybersecurity threats. FDA...

Updates on new MDR and IVDR

Compromise in MDR/IVDR Trilogues: Regulators shared that they expect that the First Reading versions will be agreed upon in mid-June 2016. As a brief reminder, the MDR (Medical Device Regulation replacing what is now called the Medical Device Directive (MDD) and IVDR...

Updated packaging standards

As you may be aware, the USP <661> guidelines for testing of containers updated on May 1st 2016. Methodize would like to take some time to clarify what these changes mean for you and how testing houses are handling these changes. The updated USP General Chapter...

27 April, 2016 13:07

In our latest edition, we cover news that Indian regulators intend to formally distinguish medical devices from drugs in order to more clearly regulate them. Developments in Brazil and the US are also included. For regular updates on medical device markets worldwide,...

Are US Reimbursement Trends Stifling Medical Device Innovation?

The increasing clout of hospital General Purchasing Organizations (GPOs), insurers and other large payers in US medical device purchasing and reimbursement may be hindering innovation, R&D and quality issues in the relentless effort to drive down healthcare costs....

Are US Reimbursement Trends Stifling Medical Device Innovation?

The increasing clout of hospital General Purchasing Organizations (GPOs), insurers and other large payers in US medical device purchasing and reimbursement may be hindering innovation, R&D and quality issues in the relentless effort to drive down healthcare costs....

FTC Launches Online Tool for Mobile Medical App Developers

The US Federal Trade Commission (FTC) has published an online tool designed to help developers of mobile medical and telehealth apps determine which laws and regulations pertain to their products. Designed with input from the Food and Drug Administration and other...