Contract Manufacturing

ONE-STOP SHOP FOR END-TO-END MEDICAL DEVICE DESIGN AND DEVELOPMENT.

Contract

Manufacturing

Let Velentium meet your manufacturing needs with our ISO 13485-certified QMS and our design and development experts in-house and on-call. We have over 15,000 sq. ft. of operating space for IPG, Lead, Quality Test, and other Medical Device manufacturing processes.

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Our Capabilities Include:

FDA Manufacturer of Record
CFR 820 Compliance
Class 7 Clean Room
Laser Can Welding
Electrode Welding
Helium Leak Detection
Injection Molding
Liquid Silicone Rubber (LSR) Molding
Implantable Leads
Full DMR Creation
Manufacturability Analysis
Box Build & Drop Ship
DHR Management
Return Product Analysis

Choose Velentium for:

Pilot Build & First Runs For Clinical Trials; Main Production; On-Shore Manufacturing

Design for Manufacturability Analysis; Development and Validation of Manufacturing Procedures

Customized Factory Test Systems with Intelligent Monitoring, Remote Access, Real-time Reporting, & Data Analytics

Customer Service Hotlines And Technical Support for Sustaining Product Engineering

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Meet Our Experts

Contract manufacturing with design & development experts in arms’ reach at all times

Terry Daglow

VP, Advanced Mechanical & Manufacturing Engineering

Satyajit “Sat” Ketkar

Director, Systems Engineering

Human Factors Engineering

Recent FDA guidance has magnified the importance of HFE. With HFE, designers can remove ambiguity from the product (formative studies) and developers can ensure the system can be used as intended (summative studies).

Embedded Cybersecurity

Velentium utilizes a Secure Development Lifecycle. We believe the best way to ensure a secure system is to weave security throughout the entire development process (similar to risk management per ISO 14971 and harmonized with IEC 62304). Christopher Gates, our SME on Cybersecurity contributed to the FDA's pre and post-market cybersecurity guidance. He is also involved with the medical device expert group for the BLE SIG (special interest group).

Automated Test Systems

Our team members have been developing test systems for medical devices for over 25 years. Our test systems are used in system characterization, design verification, manufacturing test, and returned product analysis. Often, the same equipment and software can be used throughout the testing lifecycle - allowing savings and certainty of the

Electrical
Design

Our electrical team has designed systems with near-field (inductive) and far-field communications (BLE, MedRadio). We have worked with a variety of micro-controllers and can assist with ASIC specifications. Altium is our software of choice, however, we can adapt to any special request and are familiar with a variety of other options. Our SMEs have designed numerous medical devices, including 30+ active implantable devices.

Systems Engineering

It is the intersection of technologies that often causes projects to fall behind or never work. With Velentium, you can be assured that the electronics, firmware, application software, and cloud components work seamlessly together.

Mechanical
Design

Our team members have extensive mechanical design experience on active implantables and leads. We also design device peripherals, device fixtures, and complex tooling. The majority of our work is in SolidWorks and OnShape.

Firmware

Our team is specialized in firmware for Class 2 and 3 devices, including neurostimulators, active implantables, pacemakers, LVADs, and ICDs. Our embedded systems implement communication schemes that are compliant with FDA Cybersecurity guidance. Our blend of firmware and cloud expertise enables us to implement firmware over-the-air (FOTA) in a safe and secure manner.

Mobile
Apps

Our development adheres to ISO 13485 and to IEC 62304 - differentiating our medical app development from that of a generic app firm.

Cloud-Based Applications

We create cloud solutions using a secure development process surrounding data as it is moved from an office to the cloud, and between patient and clinician applications. Our blend of cloud and firmware expertise enables us to implement firmware over-the-air (FOTA) in a safe and secure manner.

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Quality Driven

ISO 13485 Certified

Not only do we follow the standards, we helped write them! Intelligent, efficient, compliance.

Download ISO 13485 Certificate

Certified:

ISO 13485 – Quality Management Systems

Compliant:

ISO 14971 - Risk Management

IEC 62304 - Software

IEC 60601 - Electrical

IEC 62366 - Useability

ISO 14708 - Active Implantables

ISO 27001 - Information Security Management

Your IP: Designed & Built

Contract Manufacturing

Contract Manufacturing

Design &
Development

Embedded Cybersecurity

Automated Test Systems

Our Services:

Contract