NPI | New Product Implementation

NPI | New Product Implementation

The product then moves to the new product implementation (NPI) phase.

This phase includes a preliminary production portfolio comprising descriptions of the full production process, engineering conclusions, expected challenges and recommendations for production.
These well-established processes enable a seamless product transfer from design to production, which ultimately leads to significantly increased efficiency and reduced costs.

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oem audit

How to Conduct an OEM Audit for a Medical Contract Manufacturer

Conducting a medical device manufacturer audit, includes a multitude of items to examine. Especially when considering the gamut of OEM activities: from simpler manufacturing operations, to vertical production facilities. In this article we cover the most important items to consider, as well as some additional factors that demonstrate above average OEM operations.

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EU MDR 2020: What to Expect

The EU MDR allowed a 3-year transition period for medical device manufacturers to comply. This runway ends in May 2020, where after the EU MDR comes into full effect. After this point, every part of the medical device supply chain from manufacturers to importers and distributors in the EU, will be required to comply.

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