NeedlerQMS works collaboratively with your entire staff to build a Quality Management System at the right time to get your product to market.  Navigating the requirements and regulations of quality and medical device standards and applying them to a QMS can be a challenge.  

 

With experience in consumer products and medical devices, NeedlerQMS demystifies the process for start-ups and established firms alike, through ongoing training and guided implementation, to understand the key questions of any QMS:  What, Why and How?

QUALITY SYSTEMS BUILT TO COMPLY WITH

ISO 9001

for Product Quality

ISO 13485

for Medical Device development

21 CFR 820

for Medical Devices to be cleared by the FDA

INDUSTRIES SERVED

Medical Devices Manufacturers

Pharmaceutical Supply

Wellness Products

Consumer Products

Product Design Firms

Contract Manufacturing

Fabrication

Software

MedTech

For a partner who will help you build a QMS that works, call NeedlerQMS.