Powering Innovation in MedTech & Biotech: Bioparticle + Unplex Partnership
Bioparticle has partnered with Unplex to bring a powerful trio of services to medtech and biotech innovators—combining world-class engineering, regulatory expertise, and seamless digital transformation under one roof.
Together, we help organizations go from concept to compliant, connected product—faster and smarter.
MedTech Quality & Regulatory Services
Navigate compliance with confidence.
Leverage Unplex’s deep regulatory expertise to ensure your innovations meet all global standards. From ISO 13485 to FDA 21 CFR Part 820 and MDR, our teams streamline your quality systems and submissions so you can focus on innovation.
Our Services Include
QMS implementation & auditing (ISO 13485, FDA, MDR)
Technical file creation & regulatory submissions
Risk management and usability engineering
Regulatory strategy for international markets
Digital Transformation with Odoo ERP
Unify your operations with smart, scalable systems.
Get more out of your business processes with customized Odoo ERP implementations, designed for growing medtech and biotech companies. From inventory to CRM to regulatory document control—Odoo helps you operate efficiently and scale faster.
What We Deliver
Custom Odoo ERP setup & module development
Integration with R&D, QA/RA, and supply chain workflows
Secure data management and document traceability
Ongoing support and training
Engineering Services
Accelerate R&D with precision and scalability.
Our joint engineering capabilities cover everything from prototyping to product development, tailored for medtech, biotech, and life sciences applications. Whether you're scaling a new diagnostic device or optimizing a lab automation platform, our teams deliver robust, compliant, and scalable solutions.
Key Highlights
Full-cycle product development
Embedded systems and IoT integration
Mechanical, electrical, and software engineering
Custom lab automation and instrumentation