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 provides 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.

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Our team
helps your company create compliant and effective processes to start production faster.

 

Don’t compromise
production readiness.

 

Complexity of automation

Automated equipment and process validation can take months or years before any production starts. Let us lead the way and bring your company the latest in industry good practices.

Expensive hourly rates

Avoid going over budget due to unrealistic timelines, lack of project management of expensive firms with per hour pricing.

Capital expenses

Challenges arise when project timelines are not met. Capital equipment budgets can be administrative pains and can get harder to justify.

Avoid Deviations

Stop designing a production line based on the suppliers non-GMP compliant ideas that are hard or impossible to validate.

 

At Viomed, we help companies focus on innovation by accelerating the equitable access of safe and effective life science products around the globe.

Our process.

When a project is at the early stages.

Our team helps you and your suppliers conceptualize and establish specific requirements and evaluate concept designs, so your team can procure equipment with a roadmap of realistic validation plans.

When a project is at the later stages.

At a late stage, if the facility, equipment or process is already designed, we help assess the risks, develop the plan and protocols required that align with your company’s quality system and leadership timelines and expectations.

On- Demand

On demand services for Project Engineer, Project Manager, Validation Engineer, Test Engineer, Documentation Specialists are always available (Full-Time or Part Time).

We pride in aiding our customers to focus on innovative products while we take on the complexity of CQV (Qualification, Commissioning and Validation) of facilities, equipment, and processes.

  

Our Services.

Design & Master Planning

Validation Master Planning

Qualification Plan

Design Qualification

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

Clean Room Qualification

HVAC

Clean Environments / Environmental Monitoring

Building Management System

API / Bulk / Finished Pharmaceutical / Medical Device Facilities

Engineering & Automation

Automation and Controls

Aseptic Processing ( Filling lines)

Product / Process / Equipment / Utility

Validation & Qualification

 

Information Technology

Life Cycle Documentation

Verification & Validation

UDI / Serialization

Part 11 Compliance

 
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Jesús Carrillo

Principal Validation Lead & Managing Member

Jesús, a certified Medical Device Compliance Professional, is a distinguished graduate of Tecnológico de Monterrey, holding a degree in Biomedical Engineering. With an impressive career spanning over a decade, he has showcased his prowess in operational management and the successful launch of life sciences research, development, scale-up, and production facilities.

Jesús' versatile background has seen him excel in various roles across industries, including Facilities and Engineering Director, Environmental Health and Safety Director, Program and Project Manager, Property Manager, Documentation Engineer, Startup Consultant, Research Associate, and Biomedical Engineering Tech, among others.

Throughout his journey, Jesús has extended his expertise to non-profit institutions and spearheaded initiatives such as founding and directing the local chapter of Singularity University. His involvement in leadership's business startup groups highlights his commitment to fostering innovation.

With an impressive track record, Jesús has played a pivotal role in guiding over 10+ companies towards realizing their operational and business objectives. His impact ranges from empowering small startups in their scaling journey to collaborating with global Fortune 500 pharmaceutical and medical device giants on critical projects pivotal for production readiness.

 

Our Viomed team
helps your company create compliant and effective processes to start production faster.

 

Contact

Reach out so we can work on solutions to your challenges today!