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In this 2-part series of Medtech Snapshot we're joined by Square-1 Engineering Director of Delivery & Operations Trisha Aure as she walks us through the highlights of our article 'FDA Announcement: 21 CFR 820 and ISO 13485 Guidance'
Hear the areas where 21 CFR 820 differs most from ISO 13485 and what this means for medical device OEMs. Part-2 of this series will cover the process to transition and key considerations when doing so. #iso13485 #regulation #compliance #fda #21CFR #riskmanagement #medicaldevice #medtech #news #podcast #snapshot #regulatoryaffairs
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 Selecting the right medical device contract manufacturing partner is a critical decision that can significantly impact the success of your medical device development and production process. There are many advantages which come with working with a contract manufacturing partner, chief among them is it can potentially help you get out to the market quicker without having to go vertical, building up your own production system internally. The right partner can also offer cost savings as a result of their established supply chain partners, ability to scale and expertise in developing similar products.
While those advantages can indeed be a blessing to a maturing business, landing the wrong partner can also be a curse. For this reason its vital device companies utilize a strategically planned process for how they are to approach and select a new contract manufacturing partner. The more due diligence one can do on the forefront the better the likelihood will be you will see success on the back end. Here are some important criteria to consider when evaluating potential contract manufacturing partners: |
About the AuthorTravis Smith is the founder and managing director of Square-1 Engineering, a medical device consulting firm, providing end to end engineering and compliance services. He successfully served the life sciences marketplace in SoCal for over 15 years and has been recognized as a ‘40 Under 40’ honoree by the Greater Irvine Chamber of Commerce as a top leader in Orange County, CA. |
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