The people behind the work
Regulatory understanding.
Engineering perspective.
Practical experience.
We bring together the expertise your project needs, with direct involvement from experienced specialists.
Founder & President · Professional Engineer
Mauricio brings medical device experience in Canada and the United States to quality systems, risk management, post-market surveillance, and CAPA. His engineering background connects technical analysis with practical process improvement and cross-functional execution.
Focus: Quality systems · Risk management · Post-market · CAPA
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Principal Consultant
Otty specializes in quality and regulatory support for Software as a Medical Device and AI/ML technologies. Her experience includes eQMS implementation and quality improvement in evolving medical device environments.
Focus: SaMD · AI/ML devices · eQMS
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Principal Consultant
Melissa supports regulatory submissions, inspection readiness, and remediation. Her experience spans implantable and dental devices, IVDs, quality systems, FDA Warning Letters, and international market requirements.
Focus: Regulatory submissions · Audits · Remediation
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Operations · BBA
Mateo coordinates business administration, project operations, and client financial matters. He supports Enerxen’s consultants and clients with accounting, project management, and enterprise management experience.
Focus: Project coordination · Client operations
Connect on LinkedInThe right people for your project
Tell us what you’re working on and where you need support. We’ll start with your priorities.
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