Device consulting team for regulatory submissions and compliance

Rob Headshot 300x266 Device consulting team for regulatory submissions and compliance

Rob Packard, President

Our regulatory consulting team provides regulatory consulting services to medical device manufacturers regardless of size and location. Our team is global and we routinely handle medical device regulatory issues around the world.

Consulting Team Services

Our consulting team offers services in three key areas: Icons 103x300 Device consulting team for regulatory submissions and compliance

  1. Regulatory Submissions (e.g., 510k submissions, CE Marking and Canadian Medical Device Licensing)
  2. Regulatory Compliance (e.g., mock FDA inspections, ISO 13485 certification and CAPA)
  3. Continuing Education Training – webinars, public and private in-house training courses.

To learn more about our consulting team and the services we provide, to schedule a call or to request a proposal, please contact Rob Packard, President at +1.802.281.4381 or by email at rob@13485cert.com.

Medical Device Academy has grown over the years and we are continuously adding new experts to our team. Every member of our consulting services team is: 1) an independent consultant, 2) a subject matter expert in the field of medical devices, and 3) love to teach companies about regulatory and quality system compliance.

Interested in Joining our Team? Click Here for Consulting Opportunities

Consulting Team Members

 
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Jonathan C. Bretz – UDI Expert 

Jonathan C. Bretz, OT/L, MBA, RAC is a UDI Consultant, and has 35+ years medical device experience, including Regulatory Affairs/Compliance, Submission experience [510(k), CE Technical Files, Health Canada], Quality Systems (QSR, ISO 13485), Risk Mitigation (ISO 14971), Regulatory Strategies, UDI/GTINs, Product Development, Marketing & Sales, Operations and Supply Chain Management. Read More

 

 

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Leo Eisner – IEC 60601 Expert

Leonard (Leo) Eisner is the head of Eisner Safety Consultants. He is a licensed professional engineer in safety engineering, a certified Quality System lead auditor, an expert in product safety for medical electrical devices (IEC 60601 series of standards) and an expert in CE marking for the medical, in-vitro diagnostic, low voltage and other EU Directives . He has over 28 years experience in product safety.  Leo has audited for several EU Notified Bodies and has been a technical reviewer on Medical Electrical Equipment. Read More

 

 

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Brigid Glass- QMS Expert

Brigid Glass is a Quality Management Systems consultant who resides in New Zealand. She is a lively and passionate trainer who specializes in coaching smaller medical device companies to build Quality Management Systems (QMS) for compliance with ISO 13485, ISO 14971, the 21 CFR 820 (FDA QSR), and other international regulatory requirements. Read More

 

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Marcus Gould – CE Marking & EU Registration Expert

Marcus specializes in pre-market CE Marking applications and registration of medical devices in the EU. He also has extensive expert knowledge with regard to post-market interactions with Notified Bodies and Competent Authorities regarding vigilance reporting of adverse events. He holds a doctorate in biochemistry (microbiology) from the University of Oxford, holds both Chartered Biologist and Chartered Scientist status, and is a consultant editor for TOPRA’s monthly publication ‘Regulatory Rapporteur’. Read More

 

lena Huerlimann Device consulting team for regulatory submissions and complianceLena Huerlimann- Auditing Expert

Lena R Huerlimann has 18 years QC/QA/RA experience in pharmaceuticals and medical devices. Her auditing expertise includes GMP/GLP/GCP environments, as well as ISO 13485/ISO 9001/ISO 15378 facilities. Read More

 

nancydone 150x150 Device consulting team for regulatory submissions and complianceNancy Knettell – Software Verification & Validation Expert

Nancy Knettell is a IEC 62304 software verification and validation expert. She added 11 new software verification and validation procedures and associated templates to Medical Device Academy’s growing library of quality system proceduresRead More

 

Allison Komiyama 150x150 Device consulting team for regulatory submissions and complianceAllison C. Komiyama, PhD – 510k & PMA Expert

Dr. Allison Komiyama is the Principal consultant of AcKnowledge Regulatory Strategies.  She is a former FDA reviewer with expertise in medical device and combination product submissions.  While working at FDA in the Office of Device Evaluation, she acted as a lead reviewer and consult on 510k Premarket Notifications, Investigational Device Exemption (IDE) applications and Premarket approval (PMA) submissions. Her additional specialty was in biocompatibility requirements for implanted devices. She can help your company with a regulatory plan, and your FDA submissions. Read More

 

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Leo Lagrotte – FDA Inspection Expert

Leo J. Lagrotte-former Medical Device FDA Investigator -Leo served 20+ years experience with the FDA and USDA in a number of capacities as an FDA investigator, Level II Certified Medical Device Investigator (one of forty-four nationally) in 2005, and also served on FDA’s Medical Device Inspection Cadre. Read More

 

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Jon Speer – Design Control Expert

Jon Speer is a medical device veteran with more than 16 years experience. Jon specializes in helping medical device start-up companies with design project management. His experience with start-ups gave him the idea to develop a software solution to help companies document Design Controls. Read More

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