Executive Summary

• RFQUSA vetted dozens of medical injection molders across the United States and ranked Seaway Plastics as a top medical injection molding company.
• Seaway Plastics specializes in low- to mid-volume production with in-house tooling, cleanroom capabilities, and integrated secondary operations that eliminate multi-vendor coordination, while also having the capacity and equipment necessary to take on high-volume production runs of injection-molded parts.
• Their material expertise spans 14 biocompatible polymers, including high-performance resins such as PEEK, Ultem, and LCP, which require specialized processing knowledge and are frequently specified for use in Class II and Class III medical devices.

RFQUSA Recommends Seaway Plastics for Medical Injection Molding

Finding a medical injection molding company that can handle FDA-registered programs without forcing you into high-volume commitments is difficult. Most molders either lack the necessary certifications or take on projects with production volumes that don’t align with your development timeline.

Seaway Plastics combines ISO 13485 certification across five facilities with the engineering support and cleanroom capabilities that medical device manufacturers need. Read on to learn more about why RFQUSA ranked them #1 out of all other molding companies.

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What Defines a Top Medical Injection Molder?

A top medical injection molding company combines rigorous quality management systems with scientific molding processes to ensure patient safety and regulatory compliance. They act as a full-service manufacturing partner and manage risk from the initial design phase through final validation and packaging.

Core Competencies to Look For

• Rigorous Quality Management Systems: Regulatory compliance requires a robust Quality Management System (QMS) that withstands unannounced audits. Top molders implement rigorous risk management protocols and Corrective and Preventive Actions (CAPA) to maintain total lot traceability.
• Scientific Molding Implementation: Scientific molding separates the filling, packing, and holding stages to reduce variability in the manufacturing process. Competent molders use in-cavity pressure sensors and real-time data monitoring to validate part quality during the cycle.
• Lifecycle Engineering Support: Medical programs often start with low-volume prototypes before scaling to high-volume production. A capable molder supports Design for Manufacturability (DFM) analysis and manages tooling transfers without interrupting the validation chain.
• Controlled Manufacturing Environments: Manufacturing medical components demands controlled environments to manage particulate counts and bio-burden. Top facilities operate ISO Class 7 or Class 8 cleanrooms for molding and assembly.
• Vertical Integration and Assembly: Vertical integration reduces supply chain complexity by keeping secondary operations under one roof. Top molders perform ultrasonic welding and device assembly in addition to molding.

Why These Capabilities Matter

Vetting a molder based on these technical criteria ensures regulatory compliance and supply chain stability for critical medical devices.

Seaway Plastics Is a Top Medical Injection Molding Company

RFQUSA chose Seaway Plastics as our top medical injection molding company because they operate ISO 13485:2016-certified facilities that specialize in low- to mid-volume production of complex medical devices.

Why Seaway Plastics Is The Best Medical Injection Molder

Regulatory Certifications and Compliance: Seaway maintains several important certifications and FDA registration throughout its five facilities. This compliance ensures supply chain continuity and full lot traceability for critical medical programs.

Controlled Cleanroom Environments: The company operates ISO Class 7 and Class 8 cleanrooms to control particulate contamination during molding and assembly. These environments support the production of sterile-barrier packaging and sensitive surgical components that meet bio-burden requirements.

High-Performance Material Processing: Seaway offers its customers a wide range of high-temperature engineering resins, including PEEK, Ultem, and PSU, for biocompatible applications. The engineering team handles complex material requirements for overmolding and insert molding without resin degradation.

In-House Tooling and Scalability: Seaway builds molds in-house and uses Master Unit Die (MUD) inserts and standalone molds for production flexibility. This internal tooling capability supports programs from prototype through market launch without relying on third-party tool shops.

Integrated Secondary Operations: In-house capabilities include ultrasonic welding, laser marking, and EMI/RFI shielding. Consolidating these operations under one roof reduces lead times and maintains a single chain of custody for device history records.

What Separates Seaway From Other Molders

We ranked Seaway as our top medical injection molder because it has the certifications, cleanroom environments, and material expertise required by FDA-registered medical programs. Their ability to handle complex resins and secondary operations in-house eliminates the need for multi-vendor coordination, which creates delays and compliance gaps.

What Are Seaway Plastic’s Certifications & Accreditations?

Medical device manufacturers face legal and regulatory barriers if their molding partner lacks the proper certifications. Seaway holds the certifications and registrations required for FDA-regulated medical device production across multiple facility locations.

Seaway’s Certifications

ISO 13485 Certification Across All Five Facilities: ISO 13485 focuses specifically on medical device quality systems and exceeds ISO 9001 standards. Seaway’s certification covers contamination control, sterile production processes, medical device file documentation, and regulatory reporting protocols.

FDA Registration at Three Production Sites: The FDA maintains a database of registered medical device manufacturers to track quality compliance and respond to public health issues. Seaway’s Florida and California facilities undergo annual reviews to maintain this registration.

ISO 9001 Certification at Both Florida Facilities: ISO 9001 establishes uniform quality management practices across the manufacturing process. Seaway’s certification confirms standardized procedures and executive commitment to quality systems.

ITAR Compliance for Defense Applications: ITAR governs manufacturers working with defense-related parts and services. Seaway follows these protocols for programs that involve controlled exports or national security requirements.

The Importance of Multiple Certifications

Every Seaway facility is ISO 13485-certified, and three of its locations are FDA-registered. This multi-site certification structure is another important reason RFQUSA considers them a top medical injection molding company.

What Medical-Grade Materials Does Seaway Use?

Medical devices require specific material properties based on their application, sterilization method, and regulatory classification. Seaway processes a wide range of biocompatible and high-performance engineering resins that meet these varied requirements:

Materials Seaway Works With

• PEEK – Polyetheretherketone
• ABS – Acrylonitrile Butadiene Styrene
• TPU/TPE – Thermoplastic Polyurethane
• PMMA – Acrylic
• PBT – Polyester
• LCP – Liquid Crystal Polymers
• PA – Nylon
• PPE+PS – Polyphenylene Ether (Noryl)
• PUR – Polyurethane
• PC – Polycarbonate
• PEI – Ultem
• PET – Polyethylene
• LSR – Liquid Silicone Rubber
• POM – Acetal

Why Molding Compound Range Matters

Seaway works with 14 different materials, including biocompatible high-performance resins. This expertise enables them to handle complex medical device programs that require specialized plastics.

Frequently Asked Questions About Seaway Plastics

Q: What quality assurance equipment does Seaway use to verify part specifications?

A: Seaway’s quality control program uses Coordinate Measurement Machines (CMM) with multi-sensor measurement capabilities and 3D optical profilometers for dimensional verification. The company also runs First Article Inspection (FAI), Production Part Approval Process (PPAP), and process validations, including IQ, OQ, and PQ protocols.

Q: What cleanroom machine sizes does Seaway have available?

Seaway’s cleanroom injection molding equipment ranges from 44 to 180-ton machines. They also use a four-stage compressed air filtration system and a vacuum system that uses deionized air for blasting, both of which comply with federal regulations.

Q: What secondary operations does Seaway perform beyond molding?

Seaway handles in-house heat staking, thermal and ultrasonic insertion, CNC machining, ultrasonic cleaning, and laser marking. They also provide solutions for painting capabilities, including spray painting and pad printing for part finishing.

Seaway Plastics is a Medical Injection Molding Industry Leader

RFQUSA chose Seaway Plastics as our top medical injection molding company because it combines multi-site ISO 13485 certification with the technical capabilities and vertical integration required by medical device programs. Seaway’s five-facility footprint and dual-coast operations provide production flexibility and supply chain continuity that single-location molders can’t match.

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