MedTech Intelligence Volume 9 Issue 49

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	Volume 9 Issue No. 49

Business Analysis Combination Products Market Access Operations Product Development Quality/Regulatory

Featured Articles

Devine Guidance

Christopher Devine, Ph.D., Devine Guidance International Tanning Beds are Medical Devices, Who Knew?

By Christopher Devine, Ph.D.,
Devine Guidance International

Document control is a critical part of your QMS.

Patient Danger Patient Danger:
Ransomware and Cybersecurity
a Top Concern

By MedTech Intelligence Staff

ECRI releases its top 10 list of health technology hazards for 2018.

FDA FDA Issues Final Guidance for
3-D Printing

By MedTech Intelligence Staff

Recognizing that additive manufacturing is an emerging technology, the agency is providing an outline of its current thinking about the technical aspects of AM processes.

William H. Honaker Patent Litigation:
Avoiding A Nightmare

By William H. Honaker, Dickinson Wright

There are usually only losers in patent litigation, so the best strategy is avoidance.

Featured Quote

Evolving communication technologies allow equipment to report in real time not only measured and observed patient data, but also their own status.

— Dalibor Pokrajac, GuardRFID

Cybersecurity Guidance on Protecting Device Systems Against Ransomware

By MedTech Intelligence Staff

How hospitals can identify and safeguard medical device systems against an attack.

Sponsored Content

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Resource Centers

Resource Centers are single topic focused micro-sites within MedTechIntelligence.com that are portals of information on medical device components and quality systems offering news, articles, white papers, case histories and videos.

Medical Device Audits, Certification & Verification
sponsored by SGS
Quality & Regulatory Market Access Solutions
sponsored by UL
Medical Device Component
sponsored by 3M
Medical Recall
sponsored by Stericycle ExpertSOLUTIONS

Sponsored Resources

Do fewer regulatory audits sound good to you?

If you work in a Medical device company, you spend a significant amount of time hosting auditors and responding to their findings. Under the Medical Device Single Audit Program (MDSAP), one audit will cover the regulatory inspections from FDA, Health Canada, TGA, ANVISA and PMDA, potentially eliminating the time it would take to host and respond to four of these audits. UL is one of four Recognized Auditing Organizations under the MDSAP. Learn more about the program on UL’s MDSAP web page.

Upcoming Events & Webinars

January 23-24, 2018 - Premarket Submissions: 510(k) and de Novo Pathways to Market
A Virtual Conference

February 6-7, 2018 - Premarket Submissions: PMA Submissions Workshop
A Virtual Conference

February 13-14, 2018 - Medical Device Statistics for Non-Statisticians
A Virtual Conference

February 20-21, 2018 - Premarket Submissions: FDA Submissions Strategy
A Virtual Conference

First Quarter, 2018 - Cybersecurity Vulnerability Management
Washington, DC

First Quarter, 2018 - Cybersecurity Patch Management
Washington, DC

Second Quarter, 2018 - New Concepts in Risk Management
Washington, DC

Second Quarter, 2018 - Cybersecurity: Remediation of Legacy Devices
Washington, DC

April 2018 - China – the MedTech Market
Boston, MA

May 2018 - HHE & Recalls
Washington, DC

June 14-15, 2018 - MedTech Regulatory Summit
U.S. Pharmacopeia - Rockville, MD

June 26-27, 2018 - Developing Appropriate Medical Technology
Carolinas HealthCare System - Charlotte, NC