Build by Boyd | Boyd Biomedical

We design and optimize manufacturing processes to ensure they can reliably and repeatedly produce devices. We will develop the process, including selecting equipment, tooling, and process methods. We will test the process, usually on a small scale, to identify and resolve any issues. Once the process is defined, we will perform a process validation including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ). After process validation, when all testing, inspection, and documentation are completed, we will transfer the product into commercial manufacturing.

Tooling & Capital Equipment
Process Engineering
Manufacturing Transfer (IQ, OQ, PQ)

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Once a device is transferred into commercial manufacturing, we will begin regular production campaigns based on forecasts and distribution requirements. Production campaigns typically recur monthly or quarterly. Manufacturing is performed in controlled environments, adhering to our Quality Management System, which is certified to ISO 13485 and meets FDA requirements for medical device manufacturing. Inspection and testing protocols that have been defined will be implemented, and records of the process will be maintained to ensure traceability.

Devices & Components
Liquid Media
Device Assembly
Kitting
Packaging

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Our supply chain management team will assist in selecting and managing suppliers of equipment, tooling, raw materials, components, and any necessary services. Once a device is transferred into commercial manufacturing, we typically assume all ongoing supply chain management responsibilities. We align our inventory management activities with demand forecasting and production scheduling to ensure a seamless and uninterrupted supply chain. We implement appropriate quality controls, risk management practices, and documentation procedures to ensure compliance with quality and regulatory requirements.

Supplier Management
Inventory Management
Distribution & Logistics

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FREE ASSESSMENT

Build a Better Device

Get your free manufacturing assessment to help you understand where you are in the manufacturing process today, what gaps you need to fill, and the critical next steps you need to take. We start with a discovery call, and then we create a written assessment summarizing where you are today and a high-level plan outlining our recommended steps to meet your future objectives. Our assessment is free - it requires no cost or commitment from you.

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Our Approach

Discovery

We begin by understanding where you are today, what you already have in place, and your future objectives. We accomplish this in one or two discovery meetings.

Assessment

We create a written assessment summarizing where you are today and a high-level plan outlining our recommended steps to meet your future objectives.

Statement of Work

We develop a detailed statement of work for the first phase of your project. The statement of work outlines the project timeline, deliverables, costs, and key milestones.