Medical Device Manufacturers
Medical Device Academy, Inc.
345 Lincoln Hill Rd, Shrewsbury, VT 05738, United States
- Installer / service company
- 10 employees
- ISO 13485:2016
About Medical Device Academy, Inc.
Medical Device Academy, Inc. operates from Shrewsbury, Vermont, as a fully remote quality and regulatory consulting firm. The company employs ten professionals who work virtually across the Eastern Time Zone, with consultants based in North Carolina, Pennsylvania, New Jersey, and Vermont. The firm specializes in preparing FDA 510(k) submissions using the eSTAR template, FDA pre-submissions via PreSTAR, quality system implementation for FDA, ISO 13485, and MDSAP compliance, and internal quality system audits. It also provides FDA U.S. Agent services, CE Marking technical file preparation, Canadian medical device license applications, regulatory pathway analysis for U.S., European, and Canadian markets, and verification and validation test plan development. Training is delivered through a 510(k) course series and procedure-specific webinars. Clients are primarily start-up and small-to-mid-size medical device companies, including international firms seeking U.S. market entry. The company focuses on entrepreneurs at the proof-of-concept stage who need guidance on regulatory strategy, budgeting, and efficient use of limited funding. The firm emphasizes teaching clients to self-monitor compliance and avoid remediation.
Manufacturing capabilities
Core processes
Finishing & coating
Industries served
- Medical devices
Company details
- Location
- Shrewsbury, Vermont
- Company type
- Installer / service company
- Employees
- 10
- Certifications
- ISO 13485:2016
- Listed under
Frequently asked questions
Where is Medical Device Academy, Inc. located?
Medical Device Academy, Inc. is located at 345 Lincoln Hill Rd, Shrewsbury, VT 05738, United States.
What does Medical Device Academy, Inc. do?
Medical Device Academy, Inc. is listed under Medical Device Manufacturers, and its listed capabilities and products include FDA 510(k) submission preparation (eSTAR), FDA pre-submission preparation (PreSTAR), CE Marking technical file preparation, Canadian medical device license applications, Verification and validation test plan development and 510(k) project management.
What industries does Medical Device Academy, Inc. serve?
Medical Device Academy, Inc. lists Medical devices among the industries it serves.
What certifications does Medical Device Academy, Inc. have?
Certifications on file for Medical Device Academy, Inc.: ISO 13485:2016.
How many employees does Medical Device Academy, Inc. have?
Medical Device Academy, Inc. has 10 employees.
How do I request a quote from Medical Device Academy, Inc.?
Use the Request a quote button on this page to send Medical Device Academy, Inc. your requirements through FirmsLedger, or call (802) 281-4381 and visit medicaldeviceacademy.com.
What companies are similar to Medical Device Academy, Inc.?
Other Medical Device Manufacturers in Vermont listed on FirmsLedger include EQUITAS Life Sciences, LLC, Vermont Security and Numotion.