Rob Packard - Regulatory Submission and Quality System Expert

Rob1 300x246 Rob Packard   Regulatory Submission and Quality System Expert

Rob Packard – RA & QMS Expert

Rob Packard specializes in regulatory submissions and establishing new quality systems for medical device manufacturers.

Rob Packard – Contact information:

Phone 802.281.4381, or email. You can also follow him on Google+LinkedIn or Twitter.

Rob Packard – Education & Work Experience:

Rob is a graduate of UConn in Chemical Engineering. He has ~25 years experience in the medical device, pharmaceutical and biotechnology industries. Rob was a senior manager at several medical device companies—including President/CEO of a laparoscopic imaging company. His Quality Management System expertise covers all aspects of developing, training, implementing and maintaining compliance with ISO 13485 and ISO 14971.

From 2009-2012, he was a lead auditor and instructor for BSI. Rob’s specialty is regulatory submissions of high-risk medical devices for CE marking, Canadian medical device license applications and 510(k) submissions.

Rob Packard – Founder of Medical Device Academy:

He founded the Medical Device Academy in 2012 as a consulting firm focused on helping medical device companies with regulatory submissions and ISO 13485 certification. The firm has grown to seven consultants in one year. The most favorite part of his job is training others.

Rob Packard – Specialties:

CE Marking, 510k submissions, Canadian Medical Device Applications, Post-Marketing Activities, Supplier Quality, CAPA, Risk Management, Auditing, Sterilization Validation, Lean Manufacturing, Silicone Chemistry, Extrusion, Bioprocess Engineering, and Strategy. 

Rob has authored 200+ blogs on a number of topics ranging from regulatory submissions to ISO 13485 certification to management review.

Below is an excerpt from his blog, How to Prepare for an ISO 13485 Certification Stage 2 Audit-Part 2.”  

“Training Matrix for All 19 Procedures

During your Stage 1 ISO 13485 Certification audit, the auditor verifies that your company has all 19 procedures that are required. During the Stage 2 audit, however, the auditor will be reviewing training records for each employee. A training matrix is one of the best tools for verifying that your training records are completed. First, you create a table of all 19 required procedures in Excel (this is your far left column). Across the top of the top of the table, you need to list each of the employees in your organization. This would be difficult for a large organization, but most companies seeking initial ISO 13485 certification have less than 50 employees. In this matrix, you need to identify which procedures each employee must be trained on. This is one of the most common ways to identify training requirements, and color-coding the matrix works is helpful.”