510k submissions, FDA eCopy, training and quality system auditing

We specialize in helping you plan and prepare your 510k pre-submission requests, 510k submissions and De Novo applications–including FDA eCopy.

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Medical Device Academy, Inc. can help you with your medical device regulatory submissions. We specialize in 510k submissions, preparation of CE Marking Technical Files and Canadian device license submissions. We also created a new business unit that specializes in preparing, printing, validating and shipping FDA eCopies for 510k pre-submissions, 510k submissions and De Novo applications. Most of our clients are small and mid-size medical device companies that need continuing education training, and quality System Auditing for compliance. Clients that have urgent needs where time to market is critical, turn to us. Our passion is teaching medical device professionals how to prepare for future regulations and self-monitor compliance, so that they can avoid compliance remediation. Click on the download button for a description of our consulting services and our standard pricing sheet.

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Continuing Education

Medical Device Academy publishes blogs to help medical device manufacturers stay current with the regulatory requirements such as 21 CFR 820, ISO 13485, the Medical Device Directive, Canadian Medical Device Regulations and new 510k submission guidance documents. We record webinars on topics like 21 CFR 820 compliance. We offer public courses for Certified internal auditor training, and we teach courses onsite to reduce the cost of training larger groups for the Certified internal auditor training and other customized training content.


Medical Device Regulatory Submissions – Including 510k Submissions

Medical Device Academy can assist you with completion of any part of the regulatory submission process. The best place to start is with a Regulatory Pathway Analysis. However, we also prepare Pre-Sub Meeting Requests, 510k submissions, De Novo Applications, Canadian Medical Device License submissions to Health Canada, Technical file and Design dossier submissions to Notified Bodies for CE Marking and any other country in the world.


QMS Auditing & Compliance

You want to avoid an enforcement actions by regulators, but FDA recalls, FDA 483 observations from CDRH, Warning letters from CDRH and nonconformities issued by Certification bodies are a reality that is not uncommon and requires immediate and aggressive corrective action. Our consulting team can help with root cause analysis, writing and reviewing corrective action plans, verifying effectiveness of corrective actions independently and providing continuing education to prevent any future enforcement actions.