Partnering for Product Manufacturing and Fulfillment Solutions
We produce medical components and manage contract assembly for some of the largest medical device and supply companies in the world.
Many first began working with us after they fully engineered a new product but didn’t have their own production facilities to scale their company. In other cases, the companies had grown to the point where they couldn’t adequately expand their in-house production and fulfillment operations to meet new levels of demand. We integrate quality manufacturing with reliable fulfillment solutions that support the growth goals of companies in these and similar situations.
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For nearly 40 years, our large, established, family-owned business has earned a reputation for:
- Maintaining teams of experienced employees.
- Performing high-quality production.
- Providing customized, reliable fulfillment solutions.
- Offering exceptional, responsive customer service.
Peak Product Manufacturing/Fulfillment Support
We not only produce medical components in clean environments with exacting tolerances, but we also offer our medical supply customers a full range of product fulfillment support including warehousing, labeling, distribution, and other order fulfillment services. We manage these activities with the same high level of conscientious quality control as our production processes.
Many of our customers also rely on us for the final or intermediate assembly of their complex medical products. We’re even able to integrate additional plastic and non-plastic parts from a customer’s other suppliers. This assembly work might involve simply snapping or gluing pieces together, but we can also utilize more complex operations such as spin welding, ultrasonic welding, and other processes—all with full levels of documentation.
Our Qualifications for Medical Product Fulfillment
We maintain a medical-only Class 10,000 hard wall clean room and we also utilize portable clean rooms around some of our additional injection molding machines.
Our manufacturing operations have been ISO 9001 certified since 1998 through our integrated, co-located company Caroba Plastics, Inc. The scope of our Platinum ISO 9001:2015 certification includes providing plastic injection molding and cleanroom services for the medical and semiconductor industries—we maintain separate clean rooms for each.
Maintaining Documentation for Medical Product Manufacturing
Our team members stay current with and adhere to the regulatory requirements and standards for the medical products industry. We utilize the leading OEM validation protocols (IQ, OQ, and PQ) and the related mandates for process validation, measurement system analysis, design of experiment, lot number tracking, labeling, and process capability standards.
We also maintain and provide the quality-related data and documentation our medical product customers require. They’re welcome and invited to send their own quality team representatives to our site to audit our processes firsthand so they can validate and confirm our stated, agreed-upon processes.
Resin Materials Specialists
The resin materials options – and respective performance qualities – for high-tech, engineered, injected molded items are nearly unlimited. We’re familiar with the variations in polymer grades, additives, melt flows, and, of course, the ultimate product characteristics and attributes critically important for medical products.
We understand the nuances and techniques related to manufacturing with these different materials, as well as the importance of testing and verifying production along the way to help ensure the high quality our customers in the medical space have come to expect.
The Customized Peak Product Fulfillment Team is All About Quality
Each of our project teams includes experienced engineers, toolmakers, polymer engineers, and molding professionals. Our 200+ employees are all full-time professionals. We don’t use untrained, temporary workers.
Quality is key. Our manufacturing is ISO 9000 compliant and certified for quality management and quality assurance. We maintain a thorough program of internal, external, and customer audits. Our Quality Teams are led and staffed by ASQ Certified Quality Inspectors. These specialists continually document and track our procedures and processes.
As a family of companies, we’ve been in business since 1983 and many of our team members have been with us for a decade or more. That means our customers can be confident that Peak team members aren’t learning on the job.
Working green is important to us and to our customers. Our scrap reduction processes help support our clients’ environmental commitments for responsible supply chain sourcing.
Please feel free to contact us to discuss your injection molded consumer and industrial product manufacturing and fulfillment challenges.