About MedLark
A thoughtful approach to medical device and life sciences compliance
MedLark was founded to provide regulatory and quality guidance that is clear, grounded, and practical.
After years of working within industry, we saw firsthand how often compliance can become overcomplicated — driven by ever changing regulations, cross-functional handoffs, or advice that doesn’t quite fit the reality of how teams operate. MedLark was created to offer experienced support that helps teams understand what’s required, why it matters, and how to implement it in a way that holds up over time.
How We Work
Compliance isn’t just about meeting requirements — it’s about building systems that people can actually use.
Our work centers on helping medical device and life sciences companies navigate FDA, ISO 13485, MDSAP, EU MDR and global regulatory requirements with clarity and intention. We focus on building and maintaining a quality management system that reflect a company’s products, risks, and stage of growth, rather than applying one-size-fits-all approach.
Clients work directly with experienced consultants and receive guidance that is tailored, considered, and grounded in real-world application. We want your team to be able to make informed decisions when it comes to the regulations, and support the long-term compliance of your system.
Who We Work With
We support a range of organizations across the life sciences space, including early-stage startups, growing companies, and established manufacturers. Some come to us to build or strengthen quality systems, others to prepare for audits or regulatory milestones, and many for ongoing advisory support as their products and organizations evolve.
Regardless of size or stage, our clients share a common goal: they want compliance work that is thoughtful, defensible, and aligned with how they operate.
Experience & Perspective: Meet Our Leadership
Resham Ramsay, Founder and CEO of MedLark LLC
MedLark was founded by Resham Ramsay, a quality and regulatory professional with experience supporting medical device and life sciences organizations through quality system development, regulatory strategy, and audit readiness.
Resham’s work spans FDA and ISO-regulated environments and focuses on translating regulatory requirements into practical, workable systems. Her approach emphasizes clarity, consistency, and building compliance programs that can adapt as organizations grow.
Let’s Connect
If you’d like to learn more about MedLark or discuss your regulatory or quality needs, we’re happy to start with a conversation.