Rob Packard

Rob Packard Email and Phone Number

President and FDA 510k Consultant and Owner and Founder and Trainer @ Medical Device Academy, Inc.
Shrewsbury, VT, US
Rob Packard's Location
Cuttingsville, Vermont, United States, United States
Rob Packard's Contact Details
About Rob Packard

We are building the best medical device quality and regulatory consulting firm for start-ups. We are a ten-person team, but we are always looking for individuals that have 510(k) submission experience. CE Marking or Canadian Licensing experience is a huge plus. 100% of our team works remotely from home or any sunny spot with reliable internet (no shoes required). If you are one of the lucky people that join our team, you will enjoy independence and autonomy without the stress of running your own business.We are a full-service QA/RA consulting firm that specializes in helping start-up medical device companies obtain 510(k) clearance, Canadian Medical Device Licensing, and CE Marking. We also help our clients establish new ISO 13485:2016 quality systems and obtain MDSAP certification. The favorite part of my job is training. Every week I am recording new training webinars and YouTube videos. I also post a blog every week on current quality and regulatory issues.I have 20 years of experience in the medical device industry and another 10 years of experience in biotech manufacturing validation and scale-up. I am a UConn graduate in Chemical Engineering. I was Director of Quality and Regulatory Affairs at four different medical device start-ups, and I was President/CEO of a laparoscopic imaging company I co-founded in 2004. My quality management system expertise covers all aspects of developing, training, implementing, and maintaining ISO 13485 and ISO 14971 certification. From 2009-2012, I was a lead auditor and instructor for BSI - one of the largest Notified Bodies for CE Marking and MDSAP Certification.Technical Specialties: 510(k) Submissions, FDA eSTAR, Technical Writing, Public Speaking, Distance Learning, Remote Auditing, Risk Management, Design Controls, MDSAP, CE Marking, Canadian Medical Device Applications, Post-Marketing Activities, Supplier Quality, CAPA, Auditing, Sterilization Validation, Lean Manufacturing, Silicone Chemistry, Extrusion, Bioprocess Engineering, and Strategy.

Rob Packard's Current Company Details
Medical Device Academy, Inc.

Medical Device Academy, Inc.

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President and FDA 510k Consultant and Owner and Founder and Trainer
Shrewsbury, VT, US
Website:
medicaldeviceacademy.com
Employees:
8
Rob Packard Work Experience Details
  • Medical Device Academy, Inc.
    President And Fda 510K Consultant And Owner And Founder And Trainer
    Medical Device Academy, Inc.
    Shrewsbury, Vt, Us
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  • Medical Device Academy, Inc.
    President / Fda 510K Consultant / Owner / Founder / Trainer
    Medical Device Academy, Inc. Oct 2013 - Present
    Shrewsbury, Vermont, Us
    I am a FDA 510k Conultant, Owner/Founder/President of our QA/RA Firm with eleven employees. Specialize in helping start-up medical device companies obtain 510(k) clearance, Canadian Medical Device Licensing, and CE Marking. Establish new ISO 13485:2016 quality systems and obtain MDSAP certification. Weekly recording of new training webinars and YouTube videos. Weekly blog posting on current quality and regulatory issues.
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  • Fda Ecopy
    Fda 510K Consultant / Owner / Founder
    Fda Ecopy Oct 2016 - Present
    We started the new FDA eCopy service in August 2016 to print and ship 510k submissions to the FDA. In October 2018, the FDA unofficially changed the policy for an FDA eCopy to eliminate the need to print FDA submissions as a hardcopy. Instead, the FDA only requires an FDA eCopy to consist of a USB flash drive and a printed hardcopy of the cover letter. on December 16, 2019, the FDA released a new eCopy guidance that made the unofficial policy official.In July of 2022, the FDA eCopy process was updated again. The FDA created a Customer Collaboration Portal (CCP) for medical device manufacturers. Originally, the portal's purpose was to provide a place where submitters can track the status of their submissions and verify the deadlines for each stage of the submission review process. On July 19, 2022, the FDA emailed all active FDA CPP account holders that they can upload both FDA eCopy and FDA eSTAR files to the portal 100% electronically. Since our FDA 510k consulting team sends out submissions daily, everyone on the team was able to test the new process. If you have a CCP account, you no longer need to ship submissions via FedEx to the Document Control Center (DCC).On October 3, 2022, the FDA also changed the format and content for 510k submissions. The new format and content requirements for a 510k submission involve the FDA eSTAR template. There will be a one-year transition period. All 510k submissions must use the new FDA eSTAR template by October 1, 2023.In preparation for the October 1, 2023 transition deadline, we will be launching a new website: https://fdaestar.com/ this year. The new website will showcase our FDA 510k consulting team and there will be new bios and new videos for everyone on our team.
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  • Medical Devices Group
    Qa/Ra Subgroup Manager (11,000+ Members)
    Medical Devices Group Oct 2012 - Present
    Member of the newly formed Medical Device Advisory Board (http://medgroup.biz/qa-ra). The Medical Device Advisory Board gives you an opportunity to ask medical device experts a private question for free. There are 13 experts with a range of expertise from recruiting to design.Manager of the QA/RA Subgroup (9,000+ members) for Joe Hage's Medical Device Group--the single largest medical or health-related group on all of LinkedIn (300,000+ members). The Medical Devices Group is the industry's only spam-free, curated forum for intelligent conversations with medical device thought leaders.The QA/RA Subgroup provides a weekly announcement sharing news and ideas related to Quality and Regulatory Affairs. QA/RA professionals in the medical devices industry worldwide are invited to join the subgroup to help build their personal and corporate brands.The group provides:• spam-free, meaningful discussion and debate for the busy medical device executive;• job leads;• opportunities to network with medical device company representatives;• access to specialized subgroups; and,• opportunities to meet in person.
  • Packard Consulting
    External Resource For Bsi & Consultant
    Packard Consulting Feb 2008 - Dec 2012
    3rd Party Auditing for BSI. Quality System and Regulatory Affairs Consulting to medical device companies with a specialty in developing supplier quality programs--including on-site auditing of vendors. My most frequent projects include Quality System Auditing, ISO Certification Preparations, and Training Seminars.
  • Delcath Systems, Inc
    Sr. Manager, Regulatory Affairs
    Delcath Systems, Inc Mar 2012 - Oct 2012
    New York, Ny, Us
    Regulatory Affairs support for the development, launch and post-approval maintenance of the Delcath System combination product (drug/Class III medical device). Member of the design teams for product development and improvement. In-house regulatory requirements training. Resolution of regulatory compliance issues, CAPA and complaint investigation support, and support of post-market activities--including field actions, recalls, MPRs, MDRs, and vigilance.
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  • Albright Technologies, Inc.
    Director Of Qa/Ra
    Albright Technologies, Inc. Jul 2009 - Aug 2011
    Company specializes in rapid delivery of small and micro-sized silicone molded parts (i.e. - 1 week delivery). As a consultant to Albright, I assist customers with development medical devices. Consulting services offerred include: material selection, design for manufacturability, design for assembly, biocompatibility testing, sterilization validation, packaging, and regulatory submissions.
  • Cas Medical Systems
    Director Of Quality
    Cas Medical Systems Jul 2008 - Sep 2009
    Branford, Ct, Us
    Responsible for management of Corporate Quality System for CASMED in Branford, CT & Jacksonville, FL. Responsible for FDA inspections, ISO audits, Lead Auditor for Internal Audit Program, UL Audits, ITS Audits, management of 15 quality assurance personnel, and assisting the Director of Regulatory Affairs with regulatory issues. Responsible for developing a supplier quality program and training Sr. Quality Engineers to eliminate the root cause of warrantee service returns for non-invasive monitoring equipment.
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  • Conformis, Inc.
    Director Of Quality
    Conformis, Inc. Jan 2007 - Jul 2008
    Billerica, Ma, Us
    Responsible for management of Corporate Quality System for ConforMIS in Foster City, CA and Lexington, MA. Relocated and consolidated manufacturing operations in Burlington, MA (3 relocations in 12 months). Responsible for FDA inspections, ISO audits, CE Marking, management of quality assurance personnel, in-house VHP sterilization and microbiology, and assisting Senior VP of Clinicals and Regulatory Affairs. Transferred ISO Certification and CE Certificates from KEMA to BSI in first 5 months. Brought sterility testing in-house, and reduced product release time by a week. Responsible for supplier quality program involving US and European suppliers. Transferred packaging, sterilization and microbiology activities from California to Massachusetts—including purchase of capital equipment, installation, validation and start-up of new facility. Directly responsible for obtaining CE Mark of three new Class III orthopedic knee implants in 2007 & 2008.
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  • Z-Medica
    Director Of Qa/Ra
    Z-Medica Apr 2004 - Dec 2006
    Morrisville, Nc, Us
    Project manager for initial installation of the network infrastructure. Developed and implemented a Corporate Quality Management System that is ISO 13485:2003 certified from scratch. Assisted with grant proposals to the Office of Naval Research and developed a 2nd generation medical device for the company—including development of new intellectual property. Served as interim VP of Operations from April 2004 to November 2004, and managed contract manufacturing operations. Assisted new VP of Operations with relocation to Wallingford and validated new manufacturing line for in-house production. Maintained ISO and CE certificates required for international distribution. Provided regulatory strategy for new product development, managed biocompatibility testing, and performed sterilization validation. Prepared and audited 510(k) and Technical File submissions as required.
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  • Micro-Invasive Technology, Inc.
    Ceo
    Micro-Invasive Technology, Inc. Apr 2003 - Mar 2004
    Developed and executed strategies for raising capital for development of the company’s product platform. This process included establishing technical and financial milestones, budget development, conducting board meetings, approving policies and providing direction for the company. In one year, the company was incorporated, a six-member board of directors was recruited, two patents were issued, a third patent was filed, and development of the first product was completed. Every project was successfully completed on-time and under-budget.
  • Smart Drug Systems, Inc.
    Consultant
    Smart Drug Systems, Inc. 2000 - 2004
    Independent consultant performing project management services that included: vendor selection and contract negotiations, facility relocation, equipment design, equipment installation, facility start-up, recruiting, hiring, training, process validation, product development, process improvement, etc. Project included two trips to Japan for technology transfer. Co-inventor of novel silicone chemistry, micro-scale compounding process, trade secret extrusion and molding processes, and miniature extrusion equipment for the company’s drug delivery system.
  • Packard Labs, Llc
    Owner, Managing Member
    Packard Labs, Llc 2000 - 2003

Rob Packard Skills

Iso 13485 Medical Devices Fda Capa Quality System Design Control Quality Assurance Validation Regulatory Affairs Iso 14971 V&v Product Development Regulatory Submissions Ce Marking Iso Manufacturing Management Start Ups Quality Auditing Supplier Quality Strategy Gmp 21 Cfr Lean Manufacturing Technology Transfer R&d Continuous Improvement Auditing Risk Management 21 Cfr Part 11 Sterilization Pharmaceutical Industry Pma Commercialization Business Planning Licensing Market Planning Change Control Lead Auditor Electronic Submissions Canadian Medical Device Licensing Business Plan Writing Reports Ivd Management Experience Strategic Market Plans Fundraising For Start Ups 510 Submissions Clinical Evaluation Reports

Rob Packard Education Details

  • University Of Connecticut
    University Of Connecticut
    Chemical Engineering
  • World Class Product Creation 2013
    World Class Product Creation 2013

Frequently Asked Questions about Rob Packard

What company does Rob Packard work for?

Rob Packard works for Medical Device Academy, Inc.

What is Rob Packard's role at the current company?

Rob Packard's current role is President and FDA 510k Consultant and Owner and Founder and Trainer.

What is Rob Packard's email address?

Rob Packard's email address is ro****@****opy.com

What is Rob Packard's direct phone number?

Rob Packard's direct phone number is +180228*****

What schools did Rob Packard attend?

Rob Packard attended University Of Connecticut, World Class Product Creation 2013.

What are some of Rob Packard's interests?

Rob Packard has interest in Tennis And Rock Climbing, Golf, Skiig, Cycling.

What skills is Rob Packard known for?

Rob Packard has skills like Iso 13485, Medical Devices, Fda, Capa, Quality System, Design Control, Quality Assurance, Validation, Regulatory Affairs, Iso 14971, V&v, Product Development.

Who are Rob Packard's colleagues?

Rob Packard's colleagues are Alysha Chesser, Araylym Tulbasieva, Veeroo Kumar, Ethan Baker, Bhoomika Joyappa, Becca T., Lindsey Walker.

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