Services — Expertise that moves you from idea to compliant product

Bioparticle has partnered with Unplex to bring a powerful trio of services to medtech and biotech innovators — combining scientific depth in nanoparticles, regulatory rigor, digital systems, and engineering under one roof.

1. Scientific consulting — expertise in EVs, nanoparticles, nanobubbles & VLPs

Accelerate discovery, streamline analytics, and scale production for biological and synthetic nanoparticles.

Workflow design and feasibility — isolation, purification, characterization.
Process development and scale-up from bench to pilot and GMP.
Characterization and analytical strategy across NTA, flow, and microscopy.
Regulatory and quality readiness aligned to cGMP expectations.
Commercialization and partnership strategy.

2. MedTech quality & regulatory — navigate compliance with confidence

Deep regulatory expertise so your innovations meet global standards, from ISO 13485 to FDA 21 CFR Part 820 and MDR.

QMS implementation and auditing (ISO 13485, FDA, MDR).
IEC 62304 software lifecycle and technical documentation.
Technical file creation and regulatory submissions.
Risk management and usability engineering.
Regulatory strategy for international markets (FDA, CE).

3. Digital transformation — unify operations with Odoo ERP

Customized Odoo ERP implementations for growing medtech and biotech companies, from inventory to CRM to regulatory document control.

Custom Odoo ERP setup and module development.
Integration with R&D, QA/RA, and supply-chain workflows.
Secure data management and document traceability.
Ongoing support and training.

4. Engineering & product development — concept to pilot production (nine stages)

Unplex brings deep-tech product development across the full lifecycle, honed on medical devices, defense, and industrial automation and applied to life-science instrumentation and diagnostics.

Industrial Design — concept sketches and form studies; ergonomics and bench footprint; brand-aligned enclosure and finish.
System Design — requirements capture and architecture; interface and data-flow definition; feasibility and trade-off analysis.
Hardware Design — analog and digital board design; sensor and detector integration; low-noise signal acquisition.
Mechanical Design — optical and fluidic alignment; tolerance and thermal management; design-for-manufacture CAD.
Software — embedded firmware and control; acquisition and analysis pipelines; audit-ready data and clear UX.
Sourcing — vendor qualification; lead-time and BOM management; logistics and supply continuity.
Prototyping — rapid functional prototypes; system integration and bring-up; design iteration on real data.
Compliance — ISO 13485 and IEC 62304 alignment; risk management and usability; verification and validation.
Pilot Production — pilot-run setup and DFM; process and assembly documentation; a clear path to volume manufacturing.

Who we support

Academic and translational research labs.
Biotech and biopharma companies.
CROs and CDMOs working with EVs, LNPs, viruses, or VLPs.

The partnership

Unplex is a deep-tech product development and manufacturing partner spanning medical devices, defense, and industrial automation, with teams in Tucson, Bengaluru, and Ontario.

Contact Bioparticle

Email: info@bioparticle.com
Phone: +1-480-604-5662
Address: 2820 N Torino Ave, Tucson, Arizona 85712, US

Complete site content for reference: https://bioparticle.com/llms-full.txt