Global network

Our Global Partners

Consultants offering medical device registration expertise with global partnerships to secure approvals across multiple markets. Where a client needs approvals beyond Australia, we coordinate the work through vetted regulatory and quality consultancies in seven countries — one point of contact, wider reach.

Egmont

Submissions to ANVISA, CE marking, Quality System Certification.

Contact: Eduardo G. Monteiro · eduardo@egmont.com.br
Belgium obelis.net ↗

Obelis Group

EU representation, CE marking, EU product registration, technical documentation, consultancy and training. Founder of the MDLaw platform for MDR and IVDR information.

Contact: Gideon Elkayam · gideon@obelis.net

PASB

Medical device quality assurance & regulatory affairs, engineering support. MDSAP consulting support inclusive of gap analysis, QMS remediation, and mock audit support.

Contact: Paul Bassler · info@pasbtech.com

IETQAN

Testing and validation, quality management systems, CE technical file preparation, regulatory submissions and training.

Contact: Ahmed Shahean · ashahean@ietqan.com
GCC & Middle East newracs.com ↗

RACS

Certifications for ECAS, EQM, HALAL, SASO and G Mark.

Contact: Hamed Jamal · hjamal@racs-me.com
Netherlands qservegroup.com ↗

QServe

Regulatory affairs, quality assurance, training, clinical trials.

Contact: Martin De Bruin · globalreg@qservegroup.com

Track International

Regulatory affairs, quality management, environmental systems, social compliance.

Contact: Razah Shah · razashah8@gmail.com
Approvals beyond Australia?

Tell Us The Target Markets.

We'll scope the route through the right partner and stay your single point of contact for the whole project.

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