Leadership.
We have a dynamic and growing team of experts in the industry. We pride ourselves on keeping in communication and freeing you up to innovate. We are happy to meet with you at any time.
Gokhan Ozalp
Founder and President
​Bioscience Pro LLC was founded by Gokhan in 2017. Gokhan brings more than 20 years of experience in ensuring software compliance for medical devices. With deep expertise in navigating the complexities of FDA regulations for medical device software, Gokhan goes above and beyond to ensure a highly personalized customer experience. He understands the unique needs of each client and provides dedicated attention to deliver the best possible results.
Dr. Sisira Amarasinghe
Chief Technical Advisor
​Dr. Sisira K. Amarasinghe is a highly accomplished medical device industry leader with proven expertise in both Biomedical Engineering and Information Systems Engineering. He brings a unique blend of academic and industrial experience to Bioscience Pro, with a distinguished track record in the development of life-saving medical technologies. Dr. Amarasinghe leads Bioscience Pro’s highly skilled software engineering team.
Kristin Ellis
Cybersecurity Lead
Kristen brings a wealth of experience to Bioscience Pro, leading our Medical Device Cybersecurity team. Over her years in the Medical Device industry, she has thrived in various roles – as a Software Engineer, Project Manager, and now a Cybersecurity expert.
Kristen's deep understanding of Device Cybersecurity empowers her to guide customers in building robust security processes. This expertise has been instrumental in securing device applications and achieving regulatory clearances for both US and EU markets.
Hubert Lacey
Data Compliance and Privacy Lead
Mr. Lacey is the data security champion in Bioscience Pro. His extensive experience in data security best practices and unwavering commitment to patient privacy empower him to build secure medical device data storage systems that fully comply with HIPAA requirements.
His expertise extends far beyond HIPAA. Mr. Lacey is a recognized authority on EU's GDPR compliance, as well as SOC2 and HITRUST audit preparation. This comprehensive knowledge makes him an invaluable asset for device manufacturers and health IT systems, ensuring they meet the most rigorous security standards.
Tolga Ciftci
Software Verification & Validation Lead
Tolga with his strong technical background in software testing and validation methodologies, a deep understanding of medical device regulations, and a commitment
to patient safety, leads the Bioscience Pro’s verification and validation team. Tolga, with
his 20 years of experience, has developed plans and verification strategies for various
types of medical device platforms and systems.