NPD | New Product Development

NPD | New Product Development

Manufacturing excellence begins in the planning stages, even before production commences.
The company initiates the first phase, new product development (NPD) process in complete coordination with the customer.

Each product undergoes a rigorous design for manufacture (DFM) review, and a pre-process failure mode effect analysis (Pre-PFMEA). A clear process flow diagram (PFD) is provided, where all assembly steps, critical stages and test processes are well defined.

This preliminary stage removes any barriers to achieving manufacturing quality, consistency and repeatability at the initial mass production stage.

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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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