Since 1980, Shark Instruments has established itself as a premier manufacturer and global supplier of medical-grade surgical instruments. Committed to the highest standards of clinical safety and precision, our facility is ISO 13485:2016 certified and our entire product range carries the CE Mark, ensuring full compliance with international regulatory requirements. Combining four decades of traditional craftsmanship with advanced engineering, we provide healthcare professionals with durable, high-performance tools designed for the most demanding surgical environments.
Why Quality Certification Matters
To maintain these certifications, Shark Instruments adheres to a rigorous Quality Management System (QMS). Here is a breakdown of what these credentials represent:
- ISO 13485: Specifically for the medical device industry, this ensures that every stage of production—from raw material sourcing to final sterilization—is documented and controlled.
- CE Certification: This indicates that our instruments meet the essential health and safety requirements of the European Medical Device Regulation (MDR), allowing for legal distribution across the European Economic Area.
- Medical Grade Materials: We utilize high-grade stainless steel and specialized alloys that offer superior corrosion resistance and can withstand repeated autoclave sterilization cycles.
