Latest Developments, Regulations, and Security Leading Practices 

Registration and Networking: 3:30 pm – 4:00 pm
Presentation: 4:00 pm – 5:00 pm

RMRAS is extremely pleased to have Mike Pankey, Senior Manager in Grant Thornton’s Risk Advisory practice, as our speaker for the June 2023 meeting.

PRESENTATION OVERVIEW

Medical device companies must now meet new requirements issued by the FDA, in additionl to the baseline ISO 13485 standards that have been in place for years. These latest developments have been implemented in response to an increasing number of breaches and open vulnerabilities in devices, and more complex IT “supply chains”. In this session, we’ll review the latest guidance, timelines, and approaches to mitigate these risks to maintain compliance.

SPEAKER BIO

Mike is a Senior Manager in Grant Thornton’s Risk Advisory practice. With more than 12 years of security consulting and risk management experience, he has worked with clients on a variety of initiatives across the regulatory and technology landscape. He has supported pharmaceutical and medical device companies in the design and implementation of security and compliance controls, monitoring programs, and supplier management & audits. Mike has in-depth knowledge across a variety of risk domains and security standards, and is a Certified Information Systems Auditor (CISA).

Please RSVP to programs@rmras.org

Location: College Hill Library, Room L-107
[Please note that we are meeting in a different room from our usual one.  See directions below.]

Directions from Denver
Take I-25 to Hwy 36 toward Boulder
Take Hwy 36 to Sheridan Blvd, exit north
Stay on Sheridan to 112th Avenue, turn east
Go ½ mile and Front Range Community College will be on your left
Turn into the first,, lower parking lot on the western end and enter there.
Room L-107 will be on your immediate right.

Directions from Boulder
South on Highway 36 to 104th Avenue (Church Ranch Blvd) exit
East on 104th Avenue one mile to Sheridan Blvd
North on Sheridan Blvd to 112th Avenue
Go ½ mile and Front Range Community College will be on your lef
Turn into the first, lower parking lot on the western end and enter there.
Room L-107 will be on your immediate right.