About us
CREDENTIALS
Certifications & Credentials
The formal foundations of our authority, trustworthiness, and regulatory standing
ISO 13485:2016 Certified
International quality
management standard for
medical device organizations.
Our operations are fully
aligned — the same standard
we help our clients achieve.
SFDA-Licensed Authorized Representative
Fully licensed by the Saudi
Food and Drug Authority to
act as AR for overseas medical
device manufacturers in the
Kingdom of Saudi Arabia.
Saudi Commercial Registration
Registered Saudi business
entity (C.R. 1010635793) —
providing full legal standing
and accountability for all
regulatory activities.
GCC Regulatory Network
Active participation in GCC
regulatory networks and
professional associations —
keeping our team at the
forefront of regional
regulatory developments.