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Expert QMS implementation and audit support for medical device companies operating in highly regulated environments.
We provide ISO 13485 and FDA consulting, along with QMS implementation, for medical device companies that need practical, audit-ready quality systems aligned with FDA and global regulatory requirements.
Our consultants build, implement, and maintain medical device Quality Management Systems designed to meet ISO 13485 and FDA requirements, pass internal and external audits, and support long-term regulatory compliance across highly regulated environments.
Our role is to ensure consulting approaches are scientifically sound, compliant, and defensible during audits and inspections.
We provide ISO 13485 and FDA consulting, along with QMS implementation, for medical device companies that need practical, audit-ready quality systems aligned with FDA and global regulatory requirements.
Our consultants build, implement, and maintain medical device Quality Management Systems designed to meet ISO 13485 and FDA requirements, pass internal and external audits, and support long-term regulatory compliance across highly regulated environments.
Implantable Medical Devices
In Vitro Diagnostics (IVD)
Disposable Medical Devices
Reusable Medical Devices
Core capabilities include:
We focus on building systems that work in practice—not theoretical frameworks that fail under audit pressure.
Audits are a core part of an effective quality system—not an afterthought. We conduct and support:
Our audit experience spans:
Establishing a compliant and well-structured Quality Management System during product development is critical to regulatory success.
Our Pre-Market compliance support ensures your systems, documentation, and risk controls are structured to meet regulatory expectations before submission and commercialization.
We support pre-market compliance through:
Structured development processes supporting traceability, verification, and validation.
ISO 14971 based risk management embedded throughout the product lifecycle.
Comprehensive documentation supporting regulatory submissions and audit readiness.
QMS documentation and compliance structures aligned with FDA and global pre-market requirements.
Maintaining an effective QMS is critical once a device is on the market.
Our approach helps reduce risk, prevent repeat findings, and maintain regulatory confidence over time.
Complaints handling processes
CAPA development and remediation
Audit remediation and follow-up
Continuous QMS improvement & maintenance
Our experience allows us to move quickly, identify risk efficiently, and deliver solutions that work in real regulatory environments.
Years of combined consulting experience across 15 Consultants
Audits conducted
over the past
10 years
Supplier & internal audits completed in the last 4 years
Quality Management Systems implemented or remediated
Medical Device
Companies
Supported Globally
Our quality systems consulting is grounded in recognized international standards and certifications.
ISO 13485 ertified
WBENC Certified
HUB Certified
Whether you are implementing a new ISO 13485–compliant QMS, preparing for an audit, or remediating post-market findings, our consultants are ready to support your next phase of compliance with clarity and confidence.
Our quality systems consulting is grounded in recognized international standards and certifications.
Whether you are implementing a new ISO 13485–compliant QMS, preparing for an audit, or remediating post-market findings, our consultants are ready to support your next phase of compliance with clarity and confidence.
Our quality systems consulting is grounded in recognized international standards and certifications.
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