Many companies in the medical industry rely on medical device contract manufacturing, which entails working with a reliable contract manufacturer to produce precision medical devices and components. The complete process can include engineering, assisting with prototyping development, conducting full-scale production, and providing assembly services as needed.

Acro Industries, Inc. specializes in medical device contract manufacturing. We work with our customers to develop innovative solutions for various medical equipment and technologies, from assessment devices and surgical tools to medical enclosures. Learn how we can support your production needs, from prototype development to quality control, shipment, and timely delivery.

Importance of Choosing the Right Medical Device Contract Manufacturer

As the medical device manufacturing industry continues to evolve, it’s essential to choose a contract manufacturing partner that can facilitate sustained success. In addition to our ISO 9001:2015 and ITAR certifications, Acro Industries will work with you to implement innovative processes and deliver assemblies and parts that meet the medical industry’s strict regulatory standards and evolving demands, giving you optimum flexibility as you navigate the changing landscape.

As an experienced medical device contract manufacturer, Acro Industries has the resources and capabilities to help you streamline manufacturing, remain adaptable, and get the best results from your operations.

The Medical Device Production Process

To provide medical devices that are safe and effective, our production work occurs in specific, controlled stages. This is necessary in order to comply with the Food and Drug Administration’s guidelines, which extend across design, manufacturing, risk management, and clinical trial stages.

The following are the FDA-approved stages Acro Industries supports our customers to optimize and adhere to medical device production and help our customers meet long-term operational needs:

  • Device discovery and concept. The product development process begins by researching a new medical device in a controlled laboratory environment.
  • Preclinical research–prototype. Lab and animal testing take place to gauge the safety of the device or drug.
  • Pathway to approval. Following animal and lab testing, devices undergo additional testing using human subjects to confirm whether a drug or device is safe and effective.
  • FDA review. A group of experts from the FDA conducts an in-depth examination of all pertinent data regarding the device or drug, which leads to a final decision to either approve or reject it.
  • FDA post-market safety monitoring. Following approval, the FDA continuously monitors the use of drugs and devices, assessing their safety for use by the public.

In addition to strictly following these approved stages, we maintain full-service facilities and employ advanced technologies to provide precision, long-lasting medical devices and components for our customers in medical applications.

Quality Contract Manufacturing for Medical Devices by Acro Industries

To meet the high quality and safety standards of the medical industry, it’s critical to have the right contract manufacturer behind your products. Reliable experts can help complete the entire development process in adherence to FDA and other regulations, maintaining quality and compliance at every stage.

At Acro Industries, Inc., we have the cross-industry experience and capabilities needed to produce a product that balances quality with cost-effectiveness. Whether it involves sheet metal forming, metal stamping, prototyping, or welding and assembly, we’ll work with you to streamline every aspect of medical device production. We can also help you optimize your supply chain, minimize inventory exposure, and deliver systems, modules, and assemblies of superior quality.

Some of the products we work with include:

  • Bone reamers
  • Medical cabinetry and enclosures
  • Assessment devices
  • Sterilization equipment
  • Warming cabinets and refrigeration solutions
  • CT and MRI imaging equipment
  • Surgical instruments

With every solution, we provide total quality assurance, working to keep all processes compliant with all industry regulations and guidelines. As a result, you’ll never need to worry about an inferior solution compromising your business or the health and safety of your product’s end users.

Want to learn more about our offerings and discover what we can do for you? Request a quote from us today to get started.