Quality & Regulatory

Notified Body Certified Quality System and FDA Registered Facility

Quality & Regulatory

Commitment to fully meet customer quality requirements is at the core of our business practices at NeedleTech. With over three decades as a contract manufacturer to the medical device industry, we have achieved an industry-wide reputation of customer satisfaction by delivering the highest-quality products to the market.

We fully understand the stringent quality and regulatory requirements that are the expected standard for the medical industry. All our products are manufactured to meet our customers’ specifications and critical quality standards of the United States Food and Drug Administration (FDA), and the International Organization for Standardization; ISO 13485:2016.

Our quality staff is trained and experienced and can handle your stringent product needs, should they be standard or specific to only your device.

Our Quality Policy confirms our commitment to quality practices.

NeedleTech’s Quality Management System creates the foundation to fully meet regulations and standards that are the framework of our medical business.

Our systems, procedures and controls establish the consistency in manufacturing and inspection to continually meet customer product quality expectations.

Our quality practices have earned us industry wide respect as a go-to contract manufacturer for meeting challenging specifications and requirements.

NeedleTech is an FDA registered facility.

View Our ISO Certificate

Get In Touch

Want to learn more? Arrange a call with a member of our expert team

Request a Call Back