YOUR PARTNER IN BRINGING NEW TECHNOLOGIES TO MARKET
The medical industry is faced with a challenging and complex new normal. The ability to rapidly innovate new products and improve existing ones is critical in the changing global environment. Creative, reliable and patient-focused supplier partners are a key component for success.
As a trusted partner we collaborate on product designs from concept through commercialization. Fralock develops and produces advanced custom components and assemblies that not only meet critical performance requirements, but also support manufacturing and cost efficiencies downstream. Our extensive materials knowledge and advanced process capabilities can provide you design options for your device to make “What if…?” reality.
Agile and flexible, we support your needs at every stage of your product’s life cycle from rapid prototyping for proof of concept, small clinical lot builds, to full commercial production. As an extension of your product development team our expertise and services can accelerate your time to market.
A multi-disciplinary team of engineers are involved at every stage applying FRALOCK’s Technical Knowledge (FTK); our expertise in advanced converting methods and specialty materials. Our engineers provide assistance in design, prototype manufacture, process development and validation, and full commercial production.
Our established supplier network includes the world’s leading adhesive, non-woven fabric and film manufacturers who offer a wide spectrum of advanced materials Our material’s engineers will assist you with selecting the appropriate materials for safety, function, downstream processing and storage requirements.
We are specialists in processing a wide range of materials while maintaining tight dimensional tolerances. Fralock utilizes cutting edge technology to offer you a full suite of advanced capabilities:
· Multilayer Laminations
· Laser Die-cutting
· CNC Machining
· CAD Knife
· Cleanroom Processing
· Multi-level Scoring and Perforating
· Rotary Die-cutting
· Flat-bed Die-cutting
· Automated Assembly
· Packaging & Pouching
PRODUCT DEVELOPMENT PROCESS
Our Product Development Process ensures complete design control and verification and timely delivery on your critical programs.
Our cross-functional teams collaborate closely with yours through a disciplined a four stage process of Prototype Development, Process Optimization, Process Validation and Commercialization to bring your products to market.
For decades we have supplied critical to function components to the Medical Industry. Our commitment to quality, process control, and manufacturing expertise make a multitude of design options possible in the following application areas:
We are committed to the design and delivery of high quality products; our clients depend on it. A robust Quality System assures reliable products and our ISO 9001 and ISO 13485 certifications support customer requirements and regulatory requirements. We are also FDA registered and have ISO Class 8 (class 100,000) and Class 7 (10,000) clean rooms.
The Key Medical markets we serve are:
· Negative Pressure Therapy Dressings
· Biological Dressings
· Anti-microbial Dressings
· Wound Closure Devices
· In-vitro Diagnostics
· Point of Care Testing
· Molecular Diagnostics
· Lab Instrumentation
· Cardiovascular Care
· Device Assisted Drug Delivery
· Diagnostic Imaging
QUALITY AND REGULATORY COMPLIANCE?
Quality is of the utmost importance to assure device reliability and patient safety. We are committed to the design, manufacture, and delivery of high quality products.
Our robust Quality Management System assures compliance to your requirements and the appropriate regulatory requirements defined by the device classification and global markets served.
· ISO 13485 and 9001 certified
· FDA registered Medical Device Manufacturer
· ISO Class 8 and Class 7 cleanrooms
LET US MAKE A DIFFERENCE
We have earned the reputation as a leader in providing high quality engineered adhesive and film solutions. Let us contribute to your program objectives by bringing innovative and fresh ideas to make your product designs possible. Our proven track record of delivering enabling components has made our clients and us a success!
For additional information about us or to begin discussions on your project, click our Quote Request, or call 1-800-FRALOCK (372-5625)