Certifications

ISO 13485 Certification

Relying on an ISO 13485-certified company for medical devices ensures you receive products recognized in many countries as safe and dependable. Jewel Precision is an ISO 13485-certified company, and as such, we offer trustworthy medical sterilization cases and trays for medical instruments.

What Is the ISO 13485?

The ISO 13485 is a quality management system (QMS). The International Organization for Standardization (ISO) is a non-governmental, global organization that sets the standards for manufacturing and managing processes in various industries — including health care. ISO 13485 is specifically designed for organizations that design, produce, install and service medical devices. This QMS guarantees that medical devices comply with the proper regulatory compliance laws while meeting customer needs. This system safeguards customers from medical facilities like hospitals and clinics as well as their patients.

ISO updated the ISO 13485 in 2016 and this update addresses outsourcing. When an ISO-certified company outsources the development, design or servicing of any medical device, the company they work with must meet ISO 13485 standards.

Getting Certified

ISO does not perform certification, but various certification bodies (CBs) audit and certify companies. Receiving ISO 13485 certification shows a commitment to this QMS and aids in regulatory approvals. Regulators in the United States, Canada, Australia, Japan and the European Union use it.

What Are the Benefits of the ISO 13485?

Jewel Precision supplies robust medical cases and trays to medical facilities and original equipment manufacturers (OEMs) looking for superior cases to protect their medical instruments. OEMs and medical facilities can benefit from purchasing ISO-certified products. Using or retailing products from an ISO-certified company can:

• Ensure the retail and use of quality devices: The framework ISO 13485 provides helps companies manage the risks associated with creating, developing and manufacturing medical devices. This ensures that medical facilities and OEMs use or retail reliable, high-quality products.
• Boost trustworthiness: Relying on an ISO-certified company for medical devices can boost your reputation. Compliance with ISO 13485 demonstrates that a company is committed to offering safe medical devices that meet regulatory requirements.
• Increase business opportunities: If you retail products from an ISO-certified company, you can market your products globally, as ISO standards are the benchmark for regulatory bodies in various countries.

About Jewel Precision

Jewel Precision provides a range of medical sterilization cases and trays for surgical instruments. We’ve spent decades optimizing our products to withstand harsh sterilization processes and offer efficient and safe storage. Our autoclave-compatible products allow for fast cycle times and maximum steam ventilation. We offer custom cases and trays, modular systems and rigid reusable systems.

Our skillful team uses medical-grade raw materials and protective finishing options to offer cases and trays that deliver hardworking efficiency. As an ISO 13485-certified company, we’re committed to offering high-quality and safe medical products and our satisfied customers are reaping the benefits.

Find Out More About Our Trustworthy Products

To learn more about our medical cases and trays for surgical equipment or to purchase these high-quality sterilization products, contact us online today. We offer quick responses to product inquiries and timely personalized quotes.