Delta, BC (Canada), September 24, 2024 – LabTest Certification Inc. is thrilled to announce its most recent accreditation by the International Accreditation Service (IAS) as an ASCA/FDA-recognized testing laboratory for Medical Device approvals for the U.S. market.
LabTest is now one of few laboratories in the United States to receive this groundbreaking certification, marking a significant milestone in our commitment to excellence and safety in product testing.
As an ASCA-accredited laboratory, LabTest is recognized to perform testing in accordance with ISO/IEC 17025 and the ASCA program. This accreditation not only underscores our dedication to quality and precision but also enhances product safety for end-users and expedites the FDA approval process for our clients’ products.

What is ASCA?

The FDA launched the Accreditation Scheme for Conformity Assessment (ASCA) to bolster its public health mission by increasing confidence in test results provided by accredited testing laboratories. Achieving ASCA accreditation involves meeting stringent standards and undergoing periodic audits, to ensure that we consistently adhere to the highest procedural standards. This accreditation facilitates a smoother and faster FDA 510(k) process for Medical Device manufacturers.

The ASCA program does not introduce new requirements for medical device manufacturers. Instead, it aims to promote consistency and predictability across all FDA premarket submission programs. By choosing an ASCA-accredited laboratory such as LabTest Certification, medical device manufacturers can rest assured that their testing meets FDA regulatory requirements, significantly reducing the risk of FDA approval delays due to potential testing issues.

The FDA anticipates that the insights gained from the ASCA pilot program will contribute to international harmonization efforts, promoting the use of consistent standards across jurisdictions. The ASCA program is designed to enhance manufacturer and consumer confidence in medical device testing, ensuring the widespread availability of safe and effective medical devices.

LabTest Certification Inc. is happy to offer detailed information about the ASCA program and how it relates to your product. For more information and helpful resources, please contact us at info@labtestcert.com (Subject Line: LabTest ASCA Accreditation).

LabTest’s ASCA accreditation is a testament to our mission of partnering with clients to make the world a safer place.

About LabTest Certification Inc.

LabTest Certification Inc. is a leading provider of Testing, Inspection, and Certification services, dedicated to ensuring the safety and performance compliance, and quality of products across various industries. With a commitment to excellence and innovation, LabTest partners with manufacturers to navigate regulatory landscapes and help them achieve market success.

For media inquiries, please contact:
Erika Nordio
Marketing Manager
LabTest Certification Inc.
1-855-346-0444
Erika.Nordio@labtestcert.com