In 2015, CCI extended its scope beyond ISO certifications when it was appointed by the Medical Device Authority (MDA) to conduct audits for:

• GDPMD (Good Distribution Practice for Medical Devices)
• ISO 13485 (accredited by Standards Malaysia with IAF recognition, globally accepted)
• Product Verification (PV) for all product categories, both IVD and non-IVD
• FCA (Full Conformity Assessment)

Our objectives based on this appointment are:

• Ensure alignment with internal policies and regulatory requirements (MDA, DSM, MPOCC).
• Deliver clear, responsive, and user-friendly processes with minimal complexity.
• Expand our client base in China (NMPA) and Singapore, following recent pre-market acceptance announcements.
• Position CCI as one of the CABs selected by MDA for the reliance programme and as a model CAB for MDSAP.

In 2018, another key milestone was reached when Standards Malaysia accredited CCI for MSPO standards, making CCI the leading Conformity Assessment Body (CAB) in both areas.

As an independent, third-party assessment body, we are dedicated to certifying clients to internationally recognised standards. With most certifications carrying IAF recognition through Standards Malaysia, our services are globally accepted, including ISO 13485.

At CCI, we pride ourselves on a client-focused certification approach. Our auditors not only facilitate the certification process but also support lasting improvements within organisations. We view certification not as an endpoint, but as a milestone in the continuous journey toward organisational excellence. Beyond assessing compliance with ISO and industry standards, we help organisations unlock greater efficiency, productivity and long-term value through conformance.

Your Compliance Partner – Together, we CARE