What We Do
We perform internal audits for companies certified under ISO 13485:2016 (Medical Devices – Quality Management Systems). Whether you’re preparing for a surveillance audit or want an extra set of eyes on a critical process—we’ve got you covered.
About Us
Medical Device Consulting Services
Regulatory Compliance Support for Medical Device Innovators & Experts
Navigating medical device regulations can be complex, whether you're an early-stage startup or an established regulatory consultant. I provide specialized regulatory support services to help streamline compliance processes, optimize quality systems, and ensure smooth regulatory pathways.
With expertise in ISO 13485, complaint handling, QMS management, and regulatory documentation, I assist consultants and startups by handling the time-consuming aspects of compliance, allowing you to focus on innovation and strategy.
Who I Am
I'm Christian Havsgaard, a seasoned ISO 13485 auditor with hands-on industry experience. I bring precision, clarity, and a proactive mindset to every audit, so your team can stay focused on what matters.
ABOUT GUARDIAN CONSULTING
Our Mission
At Guardian Consulting, our mission is to help businesses thrive. We do this by providing comprehensive consulting services that are tailored to the unique needs of eaAt Guardian Consulting, we aim to empower medical device companies to achieve and maintain ISO 13485 compliance with confidence and clarity. We provide expert guidance, audit support, and high-quality documentation tools that simplify regulatory processes — so our clients can focus on what matters most: delivering safe, effective, and innovative medical solutions. ch client. Our team is committed to delivering top-notch results that exceed expectations.
Our Services
We offer a wide range of services at Guardian Consulting, including marketing, strategy, finance, and more. Our team has the expertise to help businesses across various industries achieve their goals. Browse our services to learn more about what we offer.
Our Approach
At Guardian Consulting, we take a collaborative approach to consulting. We work closely with our clients to understand their needs and develop solutions that are tailored to their unique challenges. Our approach is transparent, results-driven, and designed to help businesses succeed.
How This Adds Value
Avoid Fines
Support Continuous Improvement
Uncover Quality Issues
Reduce the risk of costly penalties by identifying and correcting compliance issues before external audits.
Uncover Quality Issues
Support Continuous Improvement
Uncover Quality Issues
Catch gaps and weaknesses in your processes early—before they escalate into regulatory or customer complaints.
Hold Suppliers Accountable
Support Continuous Improvement
Support Continuous Improvement
Ensure your suppliers meet the quality standards outlined in your agreements through thorough, independent checks.
Support Continuous Improvement
Support Continuous Improvement
Support Continuous Improvement
Use audit insights to fine-tune your processes, strengthen your QMS, and build a culture of ongoing quality excellence.