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.
Submissions to ANVISA, CE marking, Quality System Certification.
EU representation, CE marking, EU product registration, technical documentation, consultancy and training. Founder of the MDLaw platform for MDR and IVDR information.
Medical device quality assurance & regulatory affairs, engineering support. MDSAP consulting support inclusive of gap analysis, QMS remediation, and mock audit support.
Testing and validation, quality management systems, CE technical file preparation, regulatory submissions and training.
Certifications for ECAS, EQM, HALAL, SASO and G Mark.
Regulatory affairs, quality assurance, training, clinical trials.
Regulatory affairs, quality management, environmental systems, social compliance.
We'll scope the route through the right partner and stay your single point of contact for the whole project.
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