4 Medical Device Packaging Pitfalls to Avoid

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.

By |2021-11-10T10:22:58-08:00November 17th, 2021|LSO Blog, Medical Package Testing|

3 Often Overlooked Elements of Medical Device Sterilization

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.

By |2021-11-10T09:53:08-08:00November 9th, 2021|LSO Blog, Sterilization Validation Services|

Navigating 510k Clearance: 4 Key Steps in the Manufacturing Process

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 [...]

By |2021-11-04T11:29:31-07:00November 2nd, 2021|LSO Blog, Medical Device Manufacturing|

3 Keys to More Efficient Distribution Simulation Testing

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.

By |2021-10-26T10:02:08-07:00October 26th, 2021|LSO Blog, Medical Package Testing|

3 Benefits to Conducting Sterilization with a Turnkey Manufacturing Partner

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

By |2021-10-19T10:34:20-07:00October 13th, 2021|LSO Blog, Sterilization Validation Services|

Life Science Outsourcing Appoints John Nino as CEO

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,”

By |2021-10-07T15:42:03-07:00October 6th, 2021|LSO Blog, LSO News|

ISO 11607 – Answering Manufacturers’ Most Common Questions

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.

By |2021-09-29T14:12:26-07:00September 29th, 2021|LSO Blog, Medical Package Testing|

Medical Device Steam Sterilization and the Impact of ISO 17665

Is steam sterilization right for your medical devices? Learn about the process, including ISO 17665 standards, to make the best decision for your products.

By |2021-07-20T10:15:36-07:00July 15th, 2021|LSO Blog, Sterilization Validation Services|

3 Ways Outsourcing Loaner Kit Processing Benefits Manufacturers

How can outsourcing loaner kit processing improve your business? Read 3 ways outsourcing can benefit manufacturers.

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