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Starting Up Right

Starting Up Right

Being part of a startup can be an exhilarating experience; working together to create new and exciting products, combining the talents and vision of your co-workers, and riding on the wave of enthusiasm make the blood, sweat, and tears worth it. But just when you...
ISO 13485 and MDR

ISO 13485 and MDR

According to EU Regulation (EC) 2017/745 (MDR) and US 21 CFR 820 covering medical devices, manufacturers must demonstrate that their selected critical suppliers, contractors, and consultants meet all specified requirements, including quality requirements. These...