We help companies get back to what they do best —innovate.
Who we are.
Viomed stands as your strategic partner in the life sciences sector, offering tailored solutions to ensure operational continuity even amidst challenges. Our expertise lies in Commissioning, Qualification, and Validation (CQV), driving digital transformation, ensuring compliance, and fostering innovation.
With more than 10 years of experience, Viomed is a trusted name among companies, providing strategic insights that inform decisive actions.
We seamlessly integrate into your team, amplifying capabilities and offering precision to navigate industry intricacies. Elevate your journey in the life sciences landscape with Viomed – a transformative partnership dedicated to empowering growth and excellence at every step.
Our teams
help your company validate compliant and effective processes to start production faster.
Enhance your
production readiness.
Complexity of automation
Equipment and process validation can take months up to years to start production in addition all has to be CFR part 11 compliant.
Expensive hourly rates
Avoid going over budget due to unrealistic timelines and pricing per hour.
Capital expenses
Challenges with equipment depreciation if project deadlines are not met. Misuse of capital equipment costs can create an administrative pain.
Avoid Deviations
Going out of the change control procedures established can be the root of many problems. Stop designing a production line based on the suppliers non-GMP compliant ideas.
We at Viomed, help companies focus on innovation by accelerating the equitable access of safe and effective life science products around the globe.
Our process.
At an early stage our team helps you put together the requirements specifications and test protocols, so your team can procure equipment with any supplier and validate faster.
At a late stage if the facility or equipment is already designed, we help assess the risks, develop a plan and execute protocols that comply with your company’s quality system.
On demand talent services for Project Engineer, Project Manager, Validation Engineer, Test Engineer, Documentation Specialists.
We pride in helping customers focus on innovative products while we help with the qualification, commissioning and validation of complex facilities, equipment, and processes.
Our Services.
Design & Master Planning
Validation Master Planning
Qualification Plan
Design Qualification
Design Transfer
User Requirements Specification
Functional Requirements Specification
Equipment Requirements Specification
Software Requirements Specification
Risk Assessments
Compliance Risk Analysis
Facilities & Operations Management
Facility Commissioning
Critical Utilities Commissioning
Installation and Operational Qualification
Performance Qualification
Qualification Summary Technical Reports
HVAC
Clean Environments / Environmental Monitoring
Process Utilities
Troubleshooting
Building Management System
Quality System Audits
API / Bulk / Finished Pharmaceutical / Medical Device Facilities
Engineering & Automation
Automation and Controls
Aseptic Processing
Product / Process / Equipment / Utility
Validation & Qualification
Validation Acceptance Criterion
Information Technology
Life Cycle Documentation
Verification & Validation
UDI / Serialization
Part 11 Compliance
Equipment & Utilities
Jacketed Tanks
Vial & Equipment Washers Pill
Autoclaves
Incubators, Refrigerators, Freezers
Filling & Packaging Lines
Mixers
Isolators
Compressed Gases
Clean Steam
Humidification Systems
WFI
RODI
HVAC
PLC / HMI
SCADA
Jesús Carrillo
Principal Validation Lead & Managing Member
Jesús is a certified Medical Device Compliance Professional. He graduated from Tecnológico de Monterrey as a Biomedical Engineer. Jesús carries more than ten years of work experience in a variety of industries and positions as an expert in operational management and startup of life sciences research, development, scale-up and production facilities.
Jesús has served as the Facilities and Engineering Director, Environmental Health and Safety Director, Program and Project Manager, Property Manager, Documentation Engineer, Startup Consultant, Research Associate, Biomedical Engineering Tech and others.
Over the early career years Jesús has also served in non-for-profit institutions and groups and he was the founder and local director of the Singularity University local Chapter and was part of the leadership’s monthly business startup group.
Jesús has helped over 10+ companies achieve their business and operational goals, from small startup companies that need help scaling up to global Fortune 500 pharmaceutical and medical device companies with specific critical projects that support production readiness.
Equipment purchasing, qualification, facility startup & commissioning experience
Certified Medical Device Compliance Professional
Program Manager & Project Manager for 10+ Years
Innovation, Startup, Product Development experience
Supplier Management (QbA)
Lab equipment maintenance and operations
Medical Devices & Pharma Startup
Biosafety & Risk Assessment Experience
ISPE & ABSA Member
