In this webinar, you will learn how to prepare a verification and validation test plan for your 510(k) or De Novo submission.  Test Plan Webinar ($79) When is the Test Plan Webinar Webinar? This webinar will be live on Thursday, February 22, 2024 @ 10:30 am ET. The session will also be recorded. You can […] The post Test Plan Webinar appeared first on Medical Device Academy ..read more

This is part one of a case study on how to perform a packaging complaint investigation when packaging is found open by a customer. Overview of Packaging Complaint Investigation This case study example involves a flexible, peelable pouch made of Tyvek and a clear plastic film. This is one of the most common types of […] The post Packaging Complaint Investigation – Case Study appeared first on Medical Device Academy ..read more

Complaints handling mistakes, medical device reporting, and CAPA are the most common reasons for FDA 483 inspection observations, but why? Reasons for FDA 483s related to the CAPA process You should already be well aware that deficiencies in the CAPA process, complaints handling, and medical device reporting are the three most common reasons why the … Complaints handling mistakes – Why? Read More » The post Complaints handling mistakes – Why? appeared first on Medical Device Academy ..read more

In this article, you will learn how to hire an auditor to conduct medical device internal audits and supplier audits. Hiring and Auditor Hiring an auditor, whether as a consultant or a permanent team member, is a critical decision that can drastically improve your quality management system and foster a culture of quality, or it … Hiring an Auditor Read More » The post Hiring an Auditor appeared first on Medical Device Academy ..read more

The FDA released a new draft 510k predicate selection guidance on September 7, but the draft guidance proposes controversial additions. On September 7, 2023, a draft predicate selection guidance document was released by the FDA. Normally the release of a new draft of FDA guidance documents is anticipated and there is an obvious need for … Predicate selection guidance proposes controversial additions Read More » The post Predicate selection guidance proposes controversial additions appeared first on Medical Device Academy ..read more

Design controls can be overwhelming, but you can learn the process using this step-by-step guide to implementing design controls. Design Controls Implementation You can implement design controls at any point during the development process, but the earlier you implement your design process the more useful design controls will be. The first step of implementing design […] The post Design Controls Implementation appeared first on Medical Device Academy ..read more

The Waterfall Diagram was copied by the FDA from Health Canada and ISO 9001:1994, but everyone actually uses an iterative design process. Iterative Design – What is it? The FDA first mandated that medical device manufacturers implement design controls in 1996. Unfortunately, in 1996 the design process was described as a linear process. In reality, […] The post Iterative design is real, waterfalls are illusions appeared first on Medical Device Academy ..read more

The FDA User Fees for FY 2024, October 1, 2023 – September 30, 2024, were released on Friday, July 28, 2023. What are FDA User Fees? At the very core of it, the FDA user fees fund the FDA Office of Device Evaluation (ODE) budget. Without these user fees, the FDA cannot begin reviewing a […] The post FDA User Fees for FY 2024 released on July 28, 2023 appeared first on Medical Device Academy ..read more

This article reviews auditor shadowing as an effective auditor training technique, but we also identify five common auditor shadowing mistakes. How do you evaluate auditor competency? Somewhere in your procedure for quality audits, I’ll bet there is a section on auditor competency. Most companies require that the auditor has completed either a course for an […] The post Auditor shadowing as an effective auditor training technique appeared first on Medical Device Academy ..read more

A five-day lead auditor course is never enough. Effective quality auditor training must include practical feedback from an expert. What is required for quality auditor training? The key to training auditors to audit is consistent follow-up over a long period of time (1-2 years, depending upon the frequency of audits). I recommend following the same […] The post Seven ways to improve quality auditor training appeared first on Medical Device Academy ..read more