Medical Device Academy
Medical Device Academy is a privately held, virtual FDA regulatory consulting firm with 10 consultants that helps small and early-stage medical device companies prepare 510(k) submissions, De Novo requests, and quality management systems, while selling productized training courses, SOP libraries, and continuously updated eSTAR/PreSTAR templates.
- Company typePrivate
- Founded2013
- HeadquartersShrewsbury, United States
- Headcount1–10
- GTM typeB2B
- OfferingServices
What Medical Device Academy does
Medical Device Academy, Inc. is a privately held quality and regulatory consulting firm headquartered in Shrewsbury, Massachusetts, that operates entirely virtually with a team of 10 consultants primarily located in the Eastern Time Zone. Founded in 2013 and led by President Rob Packard (30+ years of medical device, pharma, and biotech experience, including a prior Notified Body lead auditor role), the firm specializes in supporting small medical device companies — particularly early-stage startups — through FDA 510(k) premarket notification submissions, De Novo Classification Requests, FDA pre-submissions (using PreSTAR), quality management system implementation, CE Marking, Canadian licensing, and FDA US Agent services. Approximately 80% of revenue mix is regulatory submissions and 20% is quality system implementation work.
The firm's core deliverables include flat-fee 510(k) consulting at $17,500 per submission, the 510(k) Course Series (40+ eSTAR webinars, 36+ historical webinars, electronic templates, and the eBook "How to Prepare a 510(k) in 100 Days") at $1,495, a Turnkey QMS (46+ SOPs covering ISO 13485:2016, FDA 21 CFR 820, EU MDR, and Canadian regulations) at $7,000–$8,500, the Lead Auditor Training Course v26.0 (32 lessons) at $1,900–$2,600, and individual webinars/SOPs ranging from $19 to $950. Underlying technology is a continuously updated library of eSTAR/PreSTAR electronic templates and SOPs that track FDA regulatory changes, with recent 2026 releases (eSTAR v7.0, PreSTAR v3.0) reflecting alignment with new FDA Human Factors guidance and the Quality Management System Regulation (QMSR). Free updates for the life of subscription create a compounding content asset.
The go-to-market is content-led: a YouTube channel, blog, email newsletter via AWeber, and free introductory Calendly/Zoom calls drive inbound to flat-fee consulting and productized training. Sales is led by Director of Sales Lindsey Walker, with Rob Packard handling European and Western Asian client relationships. Customers are primarily early-stage medical device startups and international companies seeking US market access, with no named enterprise customers disclosed and a horizontal segmentation across company size. The firm is wholly owned by Rob Packard, with no external funding, parent company, or institutional investment indicated.
Medical Device Academy firmographics
Firmographics- Name
- Medical Device Academy
- Legal name
- Medical Device Academy, Inc.
- Website
- https://medicaldeviceacademy.com
- Company type
- Private
- Founded year
- 2013
- Operating status
- Operating
- Headcount range
- 1–10 employees
- Short description
- Medical Device Academy is a privately held, virtual FDA regulatory consulting firm with 10 consultants that helps small and early-stage medical device companies prepare 510(k) submissions, De Novo requests, and quality management systems, while selling productized training courses, SOP libraries, and continuously updated eSTAR/PreSTAR templates.
- Ownership category
- akta.pro rank
Medical Device Academy industry classification
Industry- Product category
- Medical Device Regulatory Consulting
- NAICS
- Professional and Management Development Training (611430), Exam Preparation and Tutoring (611691), Technical and Trade Schools (6115)
- SIC
- Services-Educational Services (8200)
- akta.pro primary industry
- Healthcare & Life Sciences (EDAAAPAA)
- akta.pro secondary industries
- Healthcare & Clinical Professional Certifications (EDAAANAI), Healthcare & Clinical Professional Development (CME/CE) (EDAGANAJ), Pharmaceuticals & Biotechnology (EDABALAU)
Keywords
Where Medical Device Academy is headquartered
LocationHeadquarters
- HQ city
- Shrewsbury
- HQ country
- United States
- HQ region
- North America
Offices1 record
Markets served
Medical Device Academy business model
Business model- GTM type
- B2B
- Offering type
- Services
- Cost components
- Personnel, Technology or R&D, Marketing or Sales, Operations
Revenue model
- Regulatory Consulting Services: Flat-fee pricing for preparing FDA 510(k) submissions at $17,500. Also includes pre-submission meetings, quality system implementation, FDA US Agent services, CE Marking preparation, and Canadian License applications. Approximately 80% of work is regulatory submissions, 20% is quality system implementation.
- 510(k) Course Series: One-time purchase of $1,495 for comprehensive training course including webinars, templates, and eBook. Provides free updates to webinars and templates as FDA requirements change for the life of the subscription.
- Lead Auditor Training Course: Pre-order pricing of $1,900 per person until January 12, 2026, then increases to $2,600. Course is 100% on-demand and self-paced with 32 lessons. All updates included free for original subscriber.
- Turnkey Quality Management System: Turnkey QMS Global at $8,500 total ($2,125 x 4 monthly installments) or US-only at $7,000 total ($1,750 x 4 installments). Includes procedures, forms, logs, templates, and training webinars.
- Individual Webinars and Training: Various priced webinars ranging from $19 to $950, including Human Factors Training Series, CE Marking webinar series, MDSAP auditing, and other specialized training topics.
Pricing tiers
| Model | Billing | Price |
|---|---|---|
| One time/ perpetual license | Pay-as-you-go | FDA 510(k) Submission Consulting |
| One time/ perpetual license | Pay-as-you-go | 510(k) Course Series |
| One time/ perpetual license | Pay-as-you-go | Lead Auditor Training Course |
| One time/ perpetual license | Monthly | Turnkey QMS - Global |
| One time/ perpetual license | Monthly | Turnkey QMS - US Only |
| Unit Pricing | Pay-as-you-go | Individual Webinars |
| One time/ perpetual license | Pay-as-you-go | FDA PreSTAR Tutorial |
Go-to-market motion1 record
Distribution channels3 records
Marketing channels6 records
Medical Device Academy product offering
Product offeringCore offering
Medical Device Academy is a quality and regulatory consulting firm that helps small medical device companies prepare FDA 510(k) submissions using the eSTAR template, prepare FDA pre-submissions using the PreSTAR template, implement quality management systems for FDA, ISO 13485, and MDSAP compliance, and conduct quality system audits. The firm also sells self-paced training courses (510(k) Course Series, Lead Auditor Training) and a Turnkey QMS package of 46+ SOPs with templates and webinars.
Product overview
Medical Device Academy is a quality and regulatory consulting firm offering a comprehensive portfolio of training courses, consulting services, and quality system documentation products. The core offerings include the 510(k) Course Series (a webinar-based training program with electronic templates and eBook for FDA 510k submissions at $1,495), the Turnkey Quality Management System (46+ SOPs for ISO 13485/FDA compliance at $7,000-$8,500), and Lead Auditor Training (32-lesson on-demand course at $1,900-$2,600). These integrate with FDA eSTAR/PreSTAR electronic submission templates that are continuously updated. Additional offerings include individual SOPs, webinar training modules, FDA US Agent services, CE Marking preparation, and Canadian device licensing consulting. The company operates with a team of ten virtual consultants and provides flat-fee pricing rather than hourly billing.
Differentiator
Problem solved
Functional benefit
Products and services
- FDA 510(k) Consulting Services
Quantifiable outcome
- Average 125 days for FDA 510(k) clearance (varies by product classification from less than 90 days to more than 180 days)
- +1 more outcomes
Companies that use Medical Device Academy
Customer profileSegments3 records
Ideal customer profiles3 records
Medical Device Academy technology and API
TechnologyTechnology focussed No
API detail
- Has API
- No
- API docs
- API detail
Core technology
AI maturity
App detail
Integration2 records
Feature4 records
Medical Device Academy partnerships and signals
Strategic signalScale indicators3 records
Recent moves6 records
Expansion highlights6 records
Medical Device Academy competitors and assessment
Company assessmentBroad incumbents
- NAMSA: NAMSA is a large medical device-focused contract research organization and regulatory consulting firm offering testing, clinical, and quality services. It serves a broader enterprise client base but competes for the same 510(k), QMS, and biocompatibility testing engagements as Medical Device Academy.
- NSF Health Sciences: NSF provides medical device regulatory consulting, training, and certification services across quality systems and global market access. It overlaps directly with Medical Device Academy's ISO 13485 and CE Marking work while operating at significantly larger scale.
- BSI Group (Healthcare): BSI is a major Notified Body and standards body offering ISO 13485 certification, CE Marking, and regulatory training for medical devices. Its training catalog and certification services compete with Medical Device Academy's courses, and its Notified Body status makes it a key counterparty for any device firm pursuing EU MDR.
- TÜV SÜD (Healthcare & Medical Devices): TÜV SÜD is a global Notified Body and testing/certification provider that helps medical device manufacturers with CE Marking, ISO 13485, MDSAP, and global market access. Its training services and consulting arm compete with Medical Device Academy, particularly in EU and Canadian device licensing.
Direct peers
- Regulatory Compliance Associates (RCA): RCA provides regulatory affairs, quality systems, and compliance consulting specifically for medical device and pharmaceutical manufacturers. It overlaps directly with Medical Device Academy's FDA submission, QMS, and audit support offerings.
- RQM+: RQM+ is a regulatory and quality consulting firm serving medical device and IVD companies with submission, QMS, and clinical strategy services. It is the most direct competitor to Medical Device Academy in the small-to-mid device company segment, with overlapping 510(k), ISO 13485, and MDSAP offerings.
- Greenlight Guru: Greenlight Guru provides quality management system software purpose-built for medical device companies, including eQMS, design controls, and CAPA modules. While software rather than consulting, it targets the same early-stage device makers as Medical Device Academy and increasingly bundles educational content into its platform.
- BioTeknica: BioTeknica is a regulatory and quality consulting firm focused on medical devices and combination products, offering 510(k), De Novo, and QMS implementation services. It is a direct competitor for early-stage medical device companies seeking FDA submission support.
- StarFish Medical: StarFish Medical is a medical device design, development, and regulatory services firm that helps startups bring devices to market. It competes for the same early-stage MedTech clients and offers overlapping regulatory submission and quality system support.
- Casus Consulting: Casus Consulting is a regulatory and quality consulting firm serving medical device companies with FDA submissions, ISO 13485 implementation, and MDSAP support. It is a comparable boutique competitor targeting the same small and mid-sized device manufacturer segment.
Market position
Strengths5 records
Weaknesses5 records
Competitive moat3 records
Key risks5 records
Key highlights7 records
Customer concentration
Medical Device Academy social profiles
Digital presenceMedical Device Academy compliance and trust
Trust signalCompliance3 records
Medical Device Academy financial estimates
Financial estimateRevenue estimate
Valuation estimate
Medical Device Academy leadership team
Management profileNumber of profiles
Profiles2 records
Medical Device Academy funding detail
Funding detailFunding overview
Funding rounds
Investors
Funding detail is available on the Subscription and Enterprise plan.Contact sales →
Medical Device Academy M&A and investment
M&A and investmentM&A
Investments
M&A and investment is available on the Subscription and Enterprise plan.Contact sales →
Frequently asked questions about Medical Device Academy
What does Medical Device Academy do?
Medical Device Academy is a quality and regulatory consulting firm that helps small medical device companies prepare FDA 510(k) submissions using the eSTAR template, prepare FDA pre-submissions using the PreSTAR template, implement quality management systems for FDA, ISO 13485, and MDSAP compliance, and conduct quality system audits. The firm also sells self-paced training courses (510(k) Course Series, Lead Auditor Training) and a Turnkey QMS package of 46+ SOPs with templates and webinars.
Is Medical Device Academy a public or private company?
Medical Device Academy is a private company. It is classified as founder individual operated bootstrapped and is currently operating.
When was Medical Device Academy founded?
Medical Device Academy was founded in 2013. It employs 1 to 10 people.
Where is Medical Device Academy based?
Medical Device Academy is headquartered in Shrewsbury, United States, in the North America region.
How does Medical Device Academy make money?
Five revenue lines are on record. Regulatory Consulting Services are the primary driver. The others are 510(k) Course Series, lead Auditor Training Course, turnkey Quality Management System and individual Webinars and Training.
Who are Medical Device Academy's main competitors?
Broad incumbents on record are NAMSA, NSF Health Sciences, BSI Group (Healthcare) and TÜV SÜD (Healthcare & Medical Devices). Direct peers are Regulatory Compliance Associates (RCA), RQM+, Greenlight Guru, BioTeknica, StarFish Medical and Casus Consulting.
Does Medical Device Academy have an API?
No public API is recorded for Medical Device Academy.
What industry is Medical Device Academy in?
Medical Device Academy's product category is Medical Device Regulatory Consulting. Its primary akta.pro industry code is EDAAAPAA, Healthcare & Life Sciences, with a secondary code of EDAAANAI, Healthcare & Clinical Professional Certifications. Its NAICS code is 611430 and its SIC code is 8200.