Ensuring effective medical device packaging is easier said than done – especially when validation is involved. Life Science Outsourcing has helped countless medical and pharmaceutical startups and OEMs successfully navigate the medical package testing and validation process. With this experience, we’ve identified key pitfalls to avoid.
Too often, medical device manufacturers assume the sterilization approaches that worked in the past will work for current projects. In reality, different devices demand different sterilization and validation methods. In our latest blog post, we detail three areas startups and OEMs often overlook when it comes to medical device sterilization – and what should be done instead.
Section 510(k) of the Food, Drug, and Cosmetic Act from the Food & Drug Administration (FDA) requires device manufacturers to notify the FDA of their intent to market a medical device. 510(k) approval is mandatory [...]
Distribution simulation testing – also known as shake, rattle, and roll testing – is a critical part of bringing a medical device safely to market. The process involves a lot more than banging and denting devices to simulate the back of a shipping truck.
Sterilization is just one part of the broader manufacturing process of bringing innovative medical devices to patients and providers. But it is a critical part – and one that manufacturers cannot afford to overlook. In our latest blog post, we examine how working with a turnkey manufacturing partner can ensure sterilization efforts fit into a more strategic plan for bringing a new product to market
Life Science Outsourcing, Inc. is pleased to announce that it has appointed John Nino as CEO. “John is the perfect choice as the new CEO of LSO to take the company to its next level of performance and offer services to larger OEM’s, add additional capabilities in engineering and design, and lead the LSO team to work closely with our clients from our future expanded geographical locations,”
ISO 11607 is the defining standard for medical package testing and validation. As the consensus standard for the Food & Drug Administration (FDA), no device can expect to find its way to market without an in-depth understanding of the standard and how to meet the requirements it spells out.
EO sterilization comes with its own challenges and opportunities, particularly as COVID-19 has created significant lead-times and sterilization delays.
: Each year, about 1 in 25 U.S. hospital patients is diagnosed with at least one infection related to hospital care alone, according to the CDC. These risks underscore why the importance of effective medical device sterilization go beyond regulatory compliance.
Lots of medical device manufacturers focus on accelerated aging and successfully establishing an estimated shelf life for medical devices. But another aging test often gets overlooked – real-time aging. Learn the right time to start real-time aging and some best practices for results that comply with ISO 11607.
