We are proud to announce that Shenzhen Roundwhale Technology Co., Ltd. has been granted MDSAP certification (Medical Device Single Audit Program), issued by TÜV SÜD America Inc. in May 2026. This milestone marks a significant step forward in our global expansion strategy.
What is MDSAP?
MDSAP is the only international audit program that allows medical device manufacturers to satisfy the quality management system (QMS) requirements of five major regulatory markets through a single audit:
The program is recognized by the International Medical Device Regulators Forum (IMDRF) and fully endorsed by the participating regulatory bodies.
Currently, Canada and Brazil mandate MDSAP as a prerequisite for medical device market approval. In May 2026, Malaysia officially joined the MDSAP framework, and more countries are expected to adopt it in the future, further simplifying global market access for medical device manufacturers.
What This Means for Our Customers
One audit, five markets — MDSAP reduces redundant quality system audits, saving time and cost for our partners while streamlining market entry.
Exemption from routine FDA inspections — MDSAP‑certified manufacturers are generally exempt from the FDA’s routine surveillance audits, lowering the risk and burden of unannounced “flight” inspections.
Enhanced global trust — The certificate validates that Roundwhale’s quality management system meets the highest international standards, strengthening confidence among regulators, distributors, and end‑users.
Aligned with latest regulations — The program has been updated to align with the FDA’s new QMSR (effective February 2, 2026) and the latest MDSAP audit approach (Version 010), covering supplier management and Australia’s recall procedures.
A Certified OEM/ODM Partner in Electrotherapy
As a full‑process OEM/ODM manufacturer specializing in home‑use electrotherapy devices (TENS, EMS, Ultrasound, Magnetic Therapy, Pelvic Floor Rehabilitation, and more), Roundwhale Technology is committed to providing reliable, compliant, and innovative solutions. Our MDSAP certification — issued by TÜV SÜD — demonstrates that our quality system operates at world‑class levels.
Meet Us at WHX Miami 2026
We will be exhibiting at WHX Miami 2026 (formerly FIME) from June 17–19, 2026 at the Miami Beach Convention Center. Visit us at Booth #W55 to see our latest products:
We look forward to discussing how our MDSAP‑certified OEM/ODM capabilities can support your business with reliable, compliant electrotherapy solutions.
Schedule a private meeting: info@roovjoy.com
Post time: May-18-2026
