Phase 2 Medical Manufacturing - Medical devices contract manufacturer

Phase 2 is the innovative leader in turnkey contract manufacturing for single-use medical devices. We understand the challenges OEMs face getting a product to market. When you outsource with Phase 2, we handle the entire manufacturing process so you can allocate your resources to product and market development. As an outsource provider our expertise includes providing material procurement, new product development, manufacturing, testing, packaging, warehousing, shipping, and sterilization services.

Certification

When it comes to single-use medical device solutions, no one knows more than Phase 2. We excel at design for manufacturing, engineering, and assembly, while giving you the confidence and that comes with ISO 13485 and ISO 9001 certification and FDA registration. We're also experienced in attaining CE Mark certification for class I, IIa, & IIb medical devices. Because we understand the demands of marketing a product, we can begin assembling the Technical File while documentation and process developments are being completed.

Engineering & Design

Using a systematic and scientific approach to developing new manufacturing lines while continuously improving existing lines, Phase 2 engineers identify potential failure modes and implement steps to prevent them. They work closely with Phase 2 client partners through every step of the outsource manufacturing process to ensure that the product meets requirements and that the entire manufacturing line meets the highest standards in the medical industry.

Our engineering processes include:

  • Component Procurement and Qualification
  • New Product Development
  • Project Management
  • CAD
  • Prototyping
  • Fixture and Equipment Design
  • Assembly Line Development
  • IQ/OQ/PQ
  • Risk Management
  • Design for Manufacturability
  • Package and Sterility Validation

Contract Manufacturing

Of single use medical devices is our core business. Medical device assembly is performed in our modern temperature and humidity controlled ISO Class clean rooms. We provide manual and automated medical device assembly processes tailored to the specific needs of the clients we partner with.

Our medical device assembly processes include:

  • Ultrasonic Cleaning
  • Solvent and UV Bonding
  • Soldering
  • Ultrasonic and Spot Welding
  • Annealing
  • Hipot and Continuity Testing
  • Heat Shrinking
  • Pad Printing
  • Leak and Flow Testing
  • Burst and Peel Testing
  • Kitting
  • Packaging In Rigid Trays and Pouches

Quality

Is paramount at Phase 2. Quality is built in at every step of our processes and is the responsibility of every employee. Quality starts with our rigorous Design Transfer and Validation processes, through Supplier Controls, Process Controls, Inspection, Testing and Auditing to make sure the customer gets what they want, when they want it. The key to our success is our people and supporting our people is our ERP system. Our integrated ERP system is the center of our operation and controls BOMs, Routers, Lot and Component Traceability, Documentation, Non-conformances, and more--right down to who worked on what step, of a particular lot as well as how many parts they produced and when they produced them.

Supply Chain Management

One reason Phase 2 excels at contract manufacturing of single-use medical devices lies in our ability to control and manage supply chains. Phase 2 offers its customers the value-added service of Vendor Managed Inventory (VMI) (with and without kanban buffer stock). The result for our customers is, dramatically reduced lead times, reduction in inventory from a reduced need to carry safety stock and the reduction of paperwork by eliminating purchase-order releases. Phase 2 can even take on some of the planning function for our customers' finished goods inventory to reduce the planning load at their facilities.

Sterilization

Phase 2 utilizes a number of carefully selected contract sterilization providers to help facilitate your sterilization requirements. Our strategic partnerships with leading EtO, gamma, and E-beam providers allow us to provide a finished, validated, sterile product.

At Phase 2, we want to be your outsource contract manufacturing partner. To learn more, contact us today via the contact details below.

Products and Services

Contact Details

Phase 2 Medical Manufacturing, Inc.
Tel: +1 603 332 8900
URL: www.phase2medical.com

ISO 13485:2003 ISO 9001:2008 FDA Registered Licensed in Canada CE Marking Provided
“We are passionate about your product and will employ lean and six sigma tools coupled with the latest manufacturing technologies to facilitate project success”
“We provide a host of manual and automated medical device assembly processes tailored to your specific medical device”
“We use the APQP process to ensure quality is built in”
“Some companies manage supply chains. Phase 2 owns them. We utilize lean and six sigma tools to reduce waste and shorten lead times”
“Phase 2 utilizes a number of contract sterilization providers to help facilitate your sterilization requirements”
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