# Elexes Regulatory & Quality Compliance Consulting

> > Elexes is a regulatory and quality consulting and staff augmentation firm specializing in medical device and healthcare compliance. Elexes supports companies worldwide in obtaining approvals for medical devices, IVDs, SaMD, and other healthcare technologies by meeting FDA, EU MDR, Health Canada, TGA, and ISO 13485 requirements.

> Mission
To streamline product compliance (pre- and post-market) and accelerate market entry for life sciences and digital healthcare innovators.
Vision
To be the most trusted global partner in regulatory and quality staff augmentation and consulting for healthcare technologies.


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> ## Documentation

- [CE Marking Services](https://www.elexes.com/ce-marking-services/): Offers end-to-end CE marking support for medical devices and IVDs in compliance with EU MDR and EU IVDR regulations.
- [FDA 510(k) Submission Services](https://www.elexes.com/510k-submission/): Prepares and submits 510(k) applications to the FDA, including predicate comparison, risk analysis, and labeling review.
- [TGA Regulatory Affairs Consultant](https://www.elexes.com/tga-regulatory-affairs-consultant/): Provides end-to-end TGA regulatory consulting (Advisory and Execution) support for compliance with Australian medical device regulations.
- [ISO 13485 Consultants](https://www.elexes.com/iso-13485-consultants/): Provides ISO 13485 implementation, documentation, internal audits, and certification readiness support.
- [IVDR Consulting Services](https://www.elexes.com/ivdr-consulting/): Assists IVD companies with technical documentation, performance evaluation, and regulatory pathways under EU IVDR.

- [Medical Device Clinical Evaluation Plan and Report (CEP and CER)](https://www.elexes.com/medical-device-clinical-evaluation-report/): Elexes provides expert support for preparing clinical evaluation plans and reports  in compliance with EU MDR and other regulatory frameworks.



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