Build by Boyd | Boyd Biomedical

During process development and validation, we design and optimize the manufacturing process to ensure it can reliably and repeatedly produce devices. During this phase 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 is completed we will transfer the product into manufacturing.

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

Once a device is transferred into manufacturing, we will begin regular production campaigns based on forecasts and distribution requirements. Production campaigns will occur monthly or quarterly. Manufacturing is performed in controlled environments and in accordance with our Quality Management System which adheres to ISO 13485 and FDA requirements. Inspection and testing protocols which have been defined will be carried out and records of the process are kept ensuring traceability.

Converting
Blending & Filling
Device Assembly
Kitting
Packaging

We assume all supply chain management responsibilities. We help select and manage suppliers of equipment, tooling, raw materials, components, and any necessary services. We align our inventory management activities with demand forecasting and production scheduling ensuring an uninterrupted supply chain. We implement appropriate quality controls, risk management, and documentation practices to comply with requirements.

Supplier Management
Inventory Management
Distribution & Logistics

Your innovation Just Might change the world. But is your manufacturing up to the task?

Investing in process engineering, manufacturing, and supply chain management drives measurable outcomes.

We help you turn Just Might, into Just Mighty.

Contract manufacturing contains and reduces the costs of goods sold through lower labor costs, automation, and economies of scale.

Source: Alira Health

Contract manufacturing improves quality and product reliability through consistent compliance to quality and regulatory standards for core competencies.

Sources: Alira Health

Contract manufacturing improves innovation with production technologies, processes, and products that emerge from expertise informed by the manufacturing experience.

Source: MIT

Contract manufacturing accelerates time to market by leveraging specialized expertise, installed capacity, and vertical integration.

Source: Karkhana