Smart Manufacturing Helps Your Business

HELPING YOUR INDUSTRY

Why Attwill Medical?

  • Facilities and process control systems.
  • Cost effective and time efficient.
  • A focus on you.
WHY ATTWILL
Attwill Medical Solutions is ISO 9001:2000 and ISO 13485:2003 Certified

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Medical Device

The manufacture of a chemical-based medical device requires the ability to create a process that adheres to a variety of compliance regulations. Our experience in working with US, Canadian and EU standards gives us the perspective we need to help you scale-up your product, from a laboratory model to a working, cGMP compliant line of commercial products. Our consulting also includes the expertise to help you register with the US FDA as a medical device manufacturer.

  • US FDA registered medical device manufacturing facility
  • cGMP compliant facilities and equipment
  • cGMP and ISO 13485 compliant quality system and procedures
  • ISO 7 (Class 10,000) temperature and humidity controlled processing suites
  • Formulation / fabrication and lyophilization of chemical based medical devices
  • cGMP packaging of a wide range of medical devices
  • Formulation, packaging and lyophilization of standards and calibration solutions for in-vitro diagnostic
  • cGMP compliant vial, bottle, foil pouch packaging and kit assembly
  • cGMP compliant receiving, storage and shipping of materials, packaging and product
  • Formulation, lyophilization and packaging design, scale-up and optimization
  • Compliance consulting

Smart Manufacturing Heals All Wounds: Partnering with a Medical Device Manufacturer

One of our largest medical device customers is an international supplier of specialty wound management products. Our relationship started small, as we began working together on a product that was just emerging from development. Since then, we've helped them develop nine cGMP compliant commercial products. The client now has manufacturing and quality systems that meets standards of their own new quality organization, and we work closely with them to assure they're in full compliance to US, Canadian and EU standards.

Anteco Pharma continues to partner with this customer to exclusively manufacture these wound management products starting from chemicals and materials and ending with packaged product ready for sterilization by irradiation.