Regulatory 101 workshop for medical device industry will feature Gretchen Bowker, co-founder & COO of Pearl IRB

IMDMC regulatory 101 workshop REG 101 indy life science eventThe Indiana Medical Device Manufacturers Council (IMDMC) is hosting a workshop on May 17, 2017 designed to provide someone new to the medical device industry a background in FDA regulation and to hone the skills of more experienced practitioners. This program has been developed to provide practical examples and regulatory information through interactive teaching methods, from experts in each field. Attendees will take a hypothetical device from pathways to market, through clinical trials, promotion and advertising. Participants will then work through recalls, QSR & MDR reporting and inspections, while addressing other areas of regulation along the way.

Pearl IRB COO and co-founder, Gretchen Bowker RAC, FRAPS, will present during REG 101, which is Day 1 of the two-day workshop. REG 102 will occur the following week on May 24.

What: A workshop exploring FDA regulations of medical devices and pathways to market.

When: Wednesday, May 17, 2017, 8:00 AM to 5:00 PM EDT (REG 101) and

Wednesday, May 24, 2017 8:00 AM to 5:00 PM EDT (REG 102)

Where: The Montage – 8580 Allison Pointe Boulevard, Indianapolis, IN 46250

Are you new to the medical device industry? Do you want to learn more about the FDA and the Pathways to Market? Register here today for one of the classes or register for both at a reduced price!

Day 1 Agenda 5/17/17 (8:00 AM – 5:00 PM)

  • Breakfast is 7:30 – 8:00
  • FDA Overview & intro to Hypothetical
  • Clinical Trials/IDE’s
  • Pathways to Market 510K Requirements
  • Pathways to Market PMA Requirements
  • Other Submissions & Special Issues
  • Pre-Market QSR
  • Labeling, Advertising & Promotion
  • Panel Discussion “Linking the Pieces” and Q&A

Day 2 Agenda 5/24/17 (8:00 AM – 5:00 PM)

  • Breakfast is 7:30 – 8:00
  • Review of Hypothetical
  • Post-Market QSR
  • Complaint Handling/Medical Device Reporting
  • Sales & Marketing: Regulatory Aspects
  • Recalls and Field Corrections
  • Inspections
  • Other Liability Mechanisms
  • Enforcement
  • Panel Discussion “Linking the Pieces” and Q&A

Registration closes this week. Register today to learn from medical device industry experts and network with your peers!

Pearl Pathways exhibiting at IMDMC Annual Conference – October 27th

imdmcThe Indiana Medical Device Manufacturers Council (IMDMC) is hosting their annual conference on October 27th at the Montage in Indianapolis.  With keynote speaker Senator Dan Coats and a full day of speakers, panel discussions and exhibits, join in for networking and a great event for all involved in the industry.  Stop by our booth to meet members of our Pearl Pathways team.

April 21st, Pearl Pathways’ own Gretchen Bowker speaking at the IMDMC workshop

imdmcThe Indiana Medical Device Manufacturers Council (IMDMC) is hosting a workshop on April 21st targeted for those new to the medical device industry or for those looking for a regulatory refresher. There will be multiple presentations including one from Gretchen Bowker COO & RAC, FRAPS, on, Pathways to Market – 510(K) Requirements at 10:15am. The workshop provides a background in FDA regulations of medical devices.

What: A workshop exploring FDA regulations of medical devices and pathways to market.

When: Thursday, April 21st, 2016, 8:00 AM to 5:00 PM EDT

Where: The Montage – 8580 Allison Pointe Boulevard, Indianapolis, IN 46250

New to the medical device industry and want to learn more about the FDA regulations? Register here today! (Lunch will be provided.)

Click here to learn more about the workshop and to register for both workshops, REG 101 & 102. We hope to see you on April 21st!

Stop by Pearl Pathways’ booth at the IMDMC conference

The Indiana Medical Device Manufacturers Council (IMDMC) is hosting their annual conference on October 29th in Indianapolis. The keynote speaker will be Governor Mike Pence and Pearl Pathways will be exhibiting at the event. To register for a booth or sponsorship, click here. Visit the event page for more information.

IMDMC is hosting second workshop on September 10th

The Indiana Medical Device Manufacturers Council is hosting the second of a two-part event on September 10th. The workshop allows participants to hone their skills, while learning more about the background of the industry.

This event targets people who are new to the medical device industry, as well as those who are interested in learning more about FDA regulation. John Lockwood of Pearl Pathways will be speaking on the topic of inspections.

When: Thursday, September 10, 2015, 8:00 AM to 4:30 PM EDT

Where: The Montage (8580 Allison Pointe Boulevard, Indianapolis, IN 46250)

To read more details on the topics covered, visit the IMDMC website. To register for the event, click here.

IMDMC workshop on June 25th. Register now

The Indiana Medical Device Manufacturers Council (IMDMC) is holding an event on the background of FDA regulation for those new to the medical device field. There will be multiple presentations, including one from Pearl Pathways’ Gretchen Bowker COO & RAC on, Pathways to Market. The presentation provides a chance for those to hear more on the pathways for FDA regulation.

What: A workshop exploring all the perspectives of the FDA inspection process.

When: Thursday, June 25th, 2015, 8:00 AM to 4:30 PM EDT

Where: 8580 Allison Pointe Boulevard, Indianapolis, IN 46250 (The Montage)

New to the medical device industry and want to learn more on FDA regulation? Register here today!

To learn more about the workshop and register for REG 101 & 102 Workshop, click here.

Heidi Strunk to present on Inspection Readiness at IMDMC workshop on April 15th

imdmcPearl Pathways’ own, Heidi Strunk, RAC will be presenting at the Indiana Medical Device Manufacturers Council (IMDMC) workshop in Indianapolis, Indiana entitled, A Deep Dive Into Inspection Preparedness. The workshop provides an opportunity to hear from experts who will explore the FDA inspection process and give key tips on what you need to know and how to be prepared for an FDA inspection.

What: A workshop exploring all the perspectives of the FDA inspection process.

When: Wednesday, April 15th, 2015 8:30AM – 4:30PM EST

Where: Montage Banquet Center, Indianapolis, IN            

Are you ready for a FDA inspection? Do you want to learn more about the inspection process? Register here today! (Lunch will be provided.)

To learn more about the workshop, click here. We hope to see you there on April 15th!

November 6 – Pearl Pathways attending, sponsoring IMDMC annual conference

imdmcPearl Pathways is excited to be attending and sponsoring the IMDMC Annual Conference tomorrow, November 6 at the Montague Banquet Center in Indianapolis. This conference provides an opportunity for networking, collaboration, and discussion of recent news and trends within the medical device industry. Dr. Kimber Richter from the FDA Office of Compliance will present this year’s keynote speech on “FDA Assessment of Risk/Benefit in the post Market/Recall Space.”

When: Thursday, November 6

Where: Montague Banquet Center, 8580 Allison Pointe Blvd, Indianapolis, IN

We encourage you to stop by our exhibitor booth to meet our talented staff! For more information about IMDMC, click here.

Heidi Strunk presenting at IMDMC Regulatory 101 on August 19th

We invite you to join us at the second session of Indiana Medical Device Manufacturers Council (IMDMC)’s annual Regulatory 101 course on August 19, 2014. This is a popular event designed for staff who are new to the FDA regulatory world or those who just need a refresher. The second session will cover the post-market requirements and compliments the discussion of pre-market requirements back in May. Your attendance is encouraged, even if you were unable to join us for session one.

Pearl Pathways’ own Heidi Strunk will be presenting an overview of post-market regulatory requirements at 9:00am; we hope to see you there!

 

What: IMDMC 2014 FDA Regulatory 101 Course, Part 2.

When: August 19th from 8:00am – 5:00pm

Where: Montage Banquet Hall in Indianapolis, Indiana

 

To register for the event, click here.

Save the Date: March 27th, IMDMC Event

The legal implications of the Sunshine Law Final Rule will be discussed by a panel of experts at the March Indiana Medical Device Manufacturer’s Council (IMDMC) March event.

Topic:    Sunshine Law Final Rule: How to Ensure Compliance

When:   March 27, 2013

Where:  Montage Meeting Facility,8580 Allisonville Pointe Blvd, Indianapolis, IN 4625

Cost:     Members: $125        Nonmembers: $175

For more information and to register, click here.