Exact Medical Manufacturing, Inc.
Exact Medical offers custom capabilities in the design, development, and manufacturing of medical devices for distribution worldwide. As a multicultural company providing comprehensive services, we do more than make surgical gowns and drapes. We offer our partners peace of mind through every step, from sourcing to development to manufacturing to quality assurance to delivery. Exact Medical manufactures and distributes a large variety of equipment covers products, with numerous variations. This includes Microscope Covers, C-arm Covers, Ultrasound Probe Covers, Band Bags, Dome Bags and Video Camera Covers. All available in single sterile, Exact Medical Branded.
Company details
Find locations served, office locations
- Business Type:
- Manufacturer
- Industry Type:
- Medical Equipment
- Market Focus:
- Globally (various continents)
This company also provides solutions for other industrial applications.
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About Us
Since we tailor our products to the exact dimensions of specific surgical equipment, they fit precisely without excess plastic that could otherwise hinder use. In addition, we understand the cost of an idle operating room. That is why we design our drapes and covers ergonomically, for easy application and removal. With our products, operating rooms can be cleaned and ready for the next patient, fast.
As the owner of two facilities in China, we have the unique ability to control your manufacturing process and ensure the utmost in quality. With Exact Medical, you’ll have confidence in our people, our products, and our ability to deliver what you need, when you need it.
Exact Medical helps you realize the cost efficiencies of manufacturing in China, while adhering to rigorous international quality standards. Though China may be a world away, you can be confident that when you put your trust in Exact Medical, you’ll experience a world of difference.
Capabilities
Whether you have an existing product, need an Exact Medical standard product, or require help from our experienced staff in developing a product, we’ll work to deliver exactly what you need.
Our experienced team is here to support you through every step: design, manufacturing, quality assurance, compliance with all international regulations, quality standards, and delivery
- Production: Our efficient team provides a consistent product focused on meeting your exact needs.
- Technical Support: Engineering, prototyping, packaging, and equipment development help bring your product to market with maximum efficiency and good result.
- Logistics: We understand the logistical challenges of delivering products around the world and work continuously with our partners to ensure the most effective path to on-time delivery.
- Customer Service: Highly responsive, multicultural customer service in both the Eastern and Western hemispheres.
- Sourcing: Using qualified suppliers worldwide to ensure the right materials for your project.
Facilities
Exact Medical owns and operates two manufacturing facilities in China. We offer local control over your manufacturing while adhering to rigorous international quality standards, specifications, and certifications.
Our CPP (Critical Product Production) Room is designed specifically for manufacturing products that require stricter process and environmental controls. At Exact Medical, we match your project with the facility environment that best suits your needs.
- FDA Registered
- ISO 13485 Certified
- EC 93/42/EEC Certified
- China CFDA Registered
- Controlled Environment Manufacturing
- Certified Clean Room Manufacturing
- Warehouse Facility
- Segregated Clean Room Packaging Lines
- Fully Capable Lab for Product Testing
- Full GMP (Good Manufacturing Practices) & ISO 13485 Compliance
- GMP Non-Overlapping Material Flow
- Equipment and Process Capabilities
- Cutting
- Sewing
- Lamination
- Heat Sealing
- Band, Impulse, and Platen Sealing
- Die Cutting
- Material Slitting
- Ultrasonic Welding
- Continuous and Spot Welding
- Automated Adhesive Application
- Hot Melt Adhesive and Cold Adhesive
- Sterile Packaging
- Towel Folding
Quality
At Exact Medical, we treat every project with the same unwavering commitment to quality.
Our systematic approach to quality assurance gives Exact Medical the confidence that every step — from material sourcing, validation, production and packaging to delivery — is precise and achieves our customers’ expectations. We can say with confidence we deliver the right product every time.
A singular focus on quality through every production run.
Product Credentials
- FDA 510(k) Premarket Notification
- K121919
- K120045
- K111535
- K101598
- K101688
- K101689
- K101593
- K211969
FDA Premarket Notification meets the AAMI PB:70 Level 1 through 4 standards for Gowns and Drapes.
- ISO 10993 Biocompatible
- ISO 11135 Sterilization Validation
- ISO 11607 Packaging for Terminally Sterilized Medical Devices
- AAMI PB:70 Liquid Barrier Compliant
- EN13795 Barrier Compliant (Standard/High Performance)
- 16CFR1610:2007 – Compliant Flammability Rating
- ISO 13485:2016 Quality Management System
- CE certified under Medical Device Regulation