Medical Device ISO 13485:2016 Certification

View ISO 13485:2016 Certification

What Is Medical Device ISO 13485:2016 Certification?

ISO certifications are seals of approval from the International Organization for Standardization (ISO) that indicate a company has met specific standards of excellence for production quality management, safety, and efficiency. Medical Device ISO 13485:2016 is the standard that specifies quality management system requirements for medical device manufacturing. Achieving Medical Device ISO 13485:2016 certification means that a manufacturer’s medical devices comply with regulations to deliver high-quality patient care.

The Importance of Medical Device ISO 13485:2016 Certification for Your Medical Wire Product Needs

Having Medical Device ISO 13485:2016 certification means Marlin Steel’s quality management system is approved for medical device manufacturing. It reflects our tenacious pursuit of reliability and precision in the pharmaceutical and medical industries. For our customers, this means enhanced product quality and the assurance that our medical products will meet or exceed expectations.

Benefits of working with a Medical Device ISO 13485:2016-certified medical device supplier include:

• Access to a trusted U.S. manufacturer: By establishing a quality management system that complies with international standards, Marlin Steel can serve more global markets and international clients.
• Transparency: Our production, inspection, testing, and distribution processes are fully transparent. We track and document products from different batches to guarantee the safety and quality of every product.
• Better quality control: Our quality control team follows strict protocols and uses its findings to continually refine our production processes, resulting in higher-quality goods and more efficient order fulfillment.
• Improved brand reputation: Choosing a Medical Device ISO 13485:2016-certified vendor like Marlin Steel for your medical stainless steel wire and sheet metal needs supports your brand or organization’s reputation.

Contact Our Experts for High-Quality Wire Products

Marlin Steel’s new Medical Device ISO 13485:2016 certification demonstrates our commitment to delivering high-quality medical devices. Our custom wire forms can protect delicate surgical instruments during cleaning, streamline sterilization processes, and be transported easily, all while resisting long-term corrosion. We make all products 100% in the U.S. to give our customers the best quality with the fastest delivery.

Learn more about our medical and pharmaceutical baskets, trays, and racks, or contact us today to start your order