This is part one of a two-part series. Part two is available here. FDA Inspection FDA inspections can be daunting, especially for an organization that is expecting its first one. In part one of a two-blog series, here are five best practices to prepare your organization for success: 1: Understand why the FDA will perform […]
2022 Automotive Predictions In many ways, 2021 was a continuation of the changes brought about in 2020, a year that’s been described as “unprecedented” and “unparalleled.” In a unique way, 2021 has offered us an idea of evolving innovations and technology on the horizon for teams across industries. These changing conditions will present a variety of […]
In this post, we pull out key takeaways from a recent whitepaper written in conjunction with Beanstock Ventures on the new EU medical device regulations (EU MDR) and how they might impact medical device development. As medical device technologies have rapidly advanced in recent years, regulations governing definitions, testing, and post-market activities have struggled to […]
In the competitive world of medical device development, medical device companies can’t afford to lag behind the pack. Streamlining the design and approval process is vital to getting products to market in a timely manner. Proper documentation is key to a smooth approval process. One essential ingredient to medical device documentation is the Design History […]
Design Controls have been an FDA Quality System Regulation since 1997. Having worked on developing products in the regulated medical device industry for over 35 years, I have compiled a list of the five key takeaways for implementing design controls and achieving success in commercializing medical devices: Design Controls not only help achieve regulatory compliance, […]
Incorporating Design Controls can be a daunting task for medical device product development teams. For a variety of reasons, including unfamiliarity of regulatory expectations, inexperience with implementation, or viewing them as a burden preventing innovation, too many teams incorporate Design Controls reactively instead of proactively. Here are three ways to proactively and practically incorporate design […]
Over the last decade, digital health solutions have become increasingly important, powering revolutionary developments in areas such as robotics, genomics, diagnostics, patient/provider interactions, and many more. In our recent webinar with MDM Engineering Consultants and BeanStock Ventures, we talked about critical standards and best practices to follow. Attendees also heard critical insight from industry leaders […]
Behind every successful product and product launch lies a complicated process that can involve multiple oversight agencies, cross-functional teams, and stakeholders. Within an organization’s governance, risk management, and compliance (GRC) framework, product teams must pursue market innovation while remaining in compliance. Staying in compliance with the vast array of rules, procedures, and contract clauses that […]
If you haven’t already, check out Part I of our ASPICE 101 blog series to learn about what the standard is and why it’s important to automotive development, and Part II, where we examine the similarities and differences between ISO 26262 and ASPICE. In this post, we take a look at the goals of ASPICE and […]
If you haven’t already, check out Part I of our ASPICE 101 blog series to learn about what the standard is and why it’s important to automotive development. In this post, we take a look at ISO 26262 vs. ASPICE and examine the similarities and differences between these two important automotive standards. ISO 26262 vs. […]
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