Value. Quality Results. Custom Services
Quality and Compliance Solutions for Your MedTech Business
Value. Quality Results. Custom Services
Our mission
At VALEX COMPLIANCE, LLC. our mission is to serve as a catalytic partner for StartUps and small to medium MedTech companies, empowering them to transform groundbreaking concepts into safe, compliant, and commercially viable products. We achieve this through custom quality and regulatory pathways designed to become our client's strategic asset.
ULTIMATELY, we are here to ensure our clients operate efficiently while remaining compliant with industry standards.
What we do
AUDIT PROGRAM MANAGEMENT
AUDIT PROGRAM MANAGEMENT
AUDIT PROGRAM MANAGEMENT
The expertise of our extended consulting team includes Audit Program Management , Gap assessments and Mock Audits. Certified lead auditors with knowledge and experience in ISO 9001, ISO 13485 and ISO 17025 regulations (to name a few) are a valuable asset for our clients.
QUALITY SYSTEMS
AUDIT PROGRAM MANAGEMENT
AUDIT PROGRAM MANAGEMENT
We design, implement, and help our clients maintain a Quality Management System (QMS) that goes beyond mere compliance; it is optimized for efficiency and scalability. By integrating quality into every stage of their product's lifecycle—from design to post-market surveillance—we assist them in reducing business costs and time to market.
TRAINING
AUDIT PROGRAM MANAGEMENT
SUPPLIER MANAGEMENT
Our purpose extends to building internal Quality expertise as the business grows By demystifying regulatory requirements and best practices, we equip teams with the knowledge and confidence needed to navigate official inspections and compliance requirements, ensuring they are ready for any challenges.
SUPPLIER MANAGEMENT
AUDIT PROGRAM MANAGEMENT
SUPPLIER MANAGEMENT
We establish robust supplier management protocols that help minimize the risks common known with external vendors. From supplier qualifications, maintenance and overall supplier controls, we mitigate related risks before they evolve into liabilities.