Medical Device and Life Sciences Compliance Done Thoughtfully
MedLark helps medical device, biotech, and healthcare companies achieve and maintain FDA, ISO 13485, and global regulatory compliance with clear, guidance, practical experience, and responsive support
Regulatory and quality requirements are complex, and mistakes can be costly. Many medical device and life sciences companies struggle with:
- Quality systems that are outdated, unclear, or difficult to maintain
- Audit findings that disrupt operations, worry investors, or linger
- Keeping up to date with the latest changes in every market
MedLark Consulting provides audit-ready regulatory and quality support designed to meet regulatory expectations and align with your business goals — so compliance becomes a foundation, not a bottleneck.
Our Services
Quality Management Systems
Development, maintenance, and remediation of the QMS, in alignment with ISO 13485, 21 CFR 820, EU MDR, MDSAP, and others
Audit & Inspection Support
Mock inspections, supplier audits, CAPA support, and remediation planning for FDA and ISO audits.
Regulatory Affairs
Regulatory submissions, technical documentation support and global regulatory strategy development for medical device and life science companies
Startup & Growth Support
Scalable compliance systems and advisory support for early-stage and growing companies.
Why MedLark?
Why Companies Choose MedLark Consulting
- Senior-level regulatory and quality expertise without large-firm overhead
- Practical, audit-focused guidance grounded in real-world experience
- Direct access to experienced consultants who understand your challenges
- Tailored support for your needs, from startups to established manufacturers
We don’t believe in one-size-fits-all compliance. Our work is built around your products, risks, and operational realities, with the goal of creating systems that are compliant, defensible, and sustainable.
What people are saying
“MedLark exceeded our expectations through the execution of many global internal audits. Resham’s friendly, evidence-based approach to compliance not only identified key considerations in our QMS for improvement, but simultaneously educated many of our associates in various standards and regulations. It would be a pleasure to work with her and MedLark again!”
-Tony C.
Senior Manager, Quality Compliance
Ready to Reduce Compliance Risk with Confidence?
Whether you’re preparing for an audit, building a quality system, or scaling operations, MedLark can help you navigate your next step with clarity.
Medical Device Consultant | Regulatory & Quality System 