Our consulting team offers services in three key areas:
1. Regulatory Submissions (e.g., Breakthrough Device Designations, 513(g) submissions, Pre-Submissions, 510k submissions, Human Factors Documentation, De Novo Applications, CE Marking Technical Files, and Canadian Medical Device License Applications)
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.
We are affordable because we know your start-ups have “one egg and one basket.” We are casual. We like taking risks. We are irreverent. We make mistakes, but we learn from them. We want our work to be fascinating. We teach the most boring topic on planet earth, but we refuse to be boring. We want to be remarkable, memorable, and fun to work with. Our team is primarily located in Eastern Time Zone, with employees in North Carolina, Pennsylvania, New Jersey, Kansas, and Vermont. We all work 100% remotely, and we always have.
Our firm has three teams: FDA 510k Consultant Team, Human Factors Team, and a Sales Team. We have ten employees now, and four of the employees are qualified lead auditors. We have several subcontractors that are qualified lead auditors too.
Company Details
- Employees
- 8
- Founded
- -
- Address
- 345 Lincoln Hill Rd, Shrewsbury,vermont 05738,united States
- Industry
- Medical Equipment Manufacturing
- NAICS
-
Medical Equipment and Supplies ManufacturingSurgical and Medical Instrument ManufacturingSurgical Appliance and Supplies ManufacturingDental Equipment and Supplies ManufacturingOphthalmic Goods ManufacturingDental Laboratories
- Website
- medicaldeviceacademy.com
- Keywords
- 510(k) Submissions, CE Marking, Mock-FDA Inspections, Continuing Education for Regulatory Compliance, Canadian Medical Device Licensing, MDSAP Certification, ISO 13485:2016, De Novo Submissions.
- HQ
- Shrewsbury, Vermont
- Competitors
- Medical Device Manufacturers Association (MDMA), Medical Device Innovation Consortium (MDIC), Easy Medical Device, Medical Device Recruiters Inc, Medical Device Components LLC, Medical Device Depot, Inc., Medical Device Manufacturing, Medical Device Success, Innolitics, Medical Device Development.
Medical Device Academy, Inc. Questions
Medical Device Academy, Inc.'s website is medicaldeviceacademy.com
Medical Device Academy, Inc.'s LinkedIn profile is https://www.linkedin.com/company/medical-device-academy
Medical Device Academy, Inc. has
8 employees.
View email and phone details for 8
employees at Medical Device Academy, Inc..
Medical Device Academy, Inc.'s industry is
Medical Equipment Manufacturing
Medical Device Academy, Inc.'s top competitors are
Medical Device Manufacturers Association (Mdma),
Medical Device Innovation Consortium (Mdic),
Easy Medical Device,
Medical Device Recruiters Inc,
Medical Device Components Llc,
Medical Device Depot, Inc.,
Medical Device Manufacturing,
Medical Device Success,
Innolitics,
Medical Device Development.
Medical Device Academy, Inc.'s categories are Medical Equipment Manufacturing
Medical Device Academy, Inc.'s founding year is 2013
