About Us
We specialize in biocompatibility and toxicological risk assessment for medical devices, with strong expertise in MDR, ISO 10993, FDA, and global regulatory requirements. From biological evaluation planning to acting as your regulatory representative with notified bodies and the FDA, we guide you smoothly through the approval process.
Our team supports you with biocompatibility studies, material and substance compliance (MDR “substance” requirements, REACH, RoHS), and manufacturing risk assessments—ensuring your devices meet regulatory expectations with confidence.
We deliver high-quality, efficient, and tailored consultancy services, assembling the right experts for your project and maintaining clear communication every step of the way. Whether you need support with biocompatibility, particulate testing, or hazardous substance management, we provide customized solutions that help you get to market faster—without compromising on quality or compliance.
Priyanka Murawala, Ph.D., DABT
Founder & Principal Consultant
Dr. Murawala is a biocompatibility and regulatory strategy expert with global experience across research, industry, and medical device compliance. With a PhD in Nanobiotechnology and postdoctoral work in cancer biology and high-throughput screening at leading research institutes in Germany, she brings strong scientific depth to regulatory decision-making.
Dr. Murawala transitioned to the medical device industry in 2017, serving as a Biological Safety and Risk Manager at Heraeus Medical, where she supported CE marking and FDA submissions for multiple devices.
Now based in the U.S., she leads Eunoia Compliance LLC, helping companies develop strong biological evaluation strategies, toxicological risk assessments, and regulatory submissions aligned with ISO 10993, FDA guidance, and MDR requirements. She is recognized for her clear, science-driven approach to navigating biocompatibility and device safety.
Hiral Kriplani, Ph.D.
Biocompatibility Specialist
Dr. Kriplani is a biocompatibility and medical device safety expert with a strong foundation in microbiology and regenerative biology. She holds an M.Sc. in Microbiology and a PhD in Zoology, with research focused on gene and protein profiling in regenerative processes.
After serving as an Assistant Professor from 2017 to 2019, she transitioned into the medical device field and joined Eunoia Compliance in 2021. Dr. Kriplani now advises global medical device manufacturers on biocompatibility and safety compliance in line with ISO 10993, ISO 14971, US FDA, and EU MDR requirements.
Lindsay D’Silva, Ph.D.
Regulatory Affairs, Quality & Risk Management Expert
Dr. D’Silva is a seasoned regulatory and quality professional with deep expertise in global medical device compliance. He has successfully navigated device classification and regulatory requirements across Europe, the U.S. (FDA), Asia, and Latin America, including PRRC responsibilities, authorized representative setup, import processes, and EUDAMED registrations.
He brings strong competency in technical documentation, ISO 14971 risk management, and ISO 13485/MDSAP quality systems, with experience developing quality policies, implementing QMS procedures, and leading internal/external audits. Dr. D’Silva has also supported quality system integrations during mergers and acquisitions.
With robust experience in clinical and usability evaluations, he has managed clinical evidence generation, usability studies (animal, cadaver, and simulated-use), and particulate testing to ensure product safety and performance. His post-market surveillance leadership further strengthens device lifecycle compliance.
As a project manager, Dr. D’Silva has led cross-functional teams to deliver complex medical device projects, consistently aligning with strategic goals and regulatory expectations.