Smart medical device packaging design is becoming increasingly important as medical device companies strive to provide products of the highest quality and safety. Medical device contract packaging services offer a comprehensive solution for creating custom packaging, from design and testing to assembly and labeling.

When it comes to medical device packaging design, there are many factors to consider. The most important considerations include understanding regulatory requirements, designing packages that will protect the product while in transit, selecting appropriate materials, and incorporating features such as tamper-evident seals and label placement.

Regulatory Requirements: Medical devices must meet specific standards set forth by different regulatory agencies around the world. It is important to check with regulators in order to determine any specific requirements for medical device packaging design. Pathway Medtech can help to connect you to the correct regulatory experts for these concerns.

There are other factors that go into medical device contract packaging. Below are some of the other things to consider when moving into the packaging design phase.

Pathway Medtech Strictly Maintains:

Current Good Manufacturing Practice (CGMP) Regulations

It is essential to find a medical device contract manufacturing company that maintains the highest standards and certifications for their packaging. This includes CGMP regulations such as 21 CFR Part 820. This will ensure that all packaging materials, processes, and services are in compliance with regulatory standards.

ISO Class 6, 7, and 8 Cleanrooms

For sterile products, to ensure the highest levels of sterility and safety, medical device contract packaging should take place in ISO Class 6, 7, or 8 cleanrooms. Pathway Medtech’s medical device experts have validated and certified cleanrooms that meet these requirements.

ISO 13485:2016 Certification

Medical device contract packaging should also be conducted in a facility that is ISO 13485:2016 certified. This certification ensures that medical devices and their packaging meet the highest standards of safety, quality, and performance.

Product and Packaging Validation Standards

Pathway Medtech’s experienced medical device experts can help to validate the product and its packaging in accordance with the regulatory requirements. This includes validation of sealing processes, package integrity testing, and other quality control measures.

These are just a few of the many considerations for medical device packaging design and contract manufacturing services. Medical device companies should always seek out qualified and certified partners who understand their specific needs and can provide solutions that meet or exceed industry standards. Pathway Medtech is one such partner that specializes in medical device contract packaging services.

It is important to note: the above considerations are only the beginning when it comes to medical device packaging design; there are many more factors to consider throughout the process.

Rigorous Medical Device Packaging Design Standards

At Pathway Medtech, we understand the importance of designing quality medical device packages with safety in mind. Our medical device supply chain management approach ensures the safe delivery of your product from the design phase through completion, while also meeting customer expectations and regulatory requirements.

Tamper-Evident Seals: Medical devices must be packaged securely to ensure that the contents remain sterile and intact throughout transit. Tamper-evident seals are an essential element of medical device packaging design to maintain product security and integrity. Pathway Medtech provides tamper-evident seals for medical devices, along with other custom labeling services.

Label Placement: Medical device labels provide critical information about the device, including product name, manufacturer, and other important information. Medical device labels must be placed in a specific location for easy identification during transit. Pathway Medtech provides labeling services to ensure that medical devices are properly labeled according to regulations and standards.

Materials: Medical device packaging must be designed using materials that protect the product during storage and transportation. Selecting appropriate barrier materials, such as moisture-resistant films, is important for maintaining a product’s shelf life and ensuring its safe arrival.

ESD, or Electrostatic Discharge Packaging: Medical device packaging must also meet ESD requirements. Pathway Medtech offers ESD-protecting materials and processes to protect medical devices from electrostatic damage during transit.

 Medical Device Contract Packaging You Can Trust

Standards and certifications are important, as is the utilization of the safest and most effective materials. Whether you are planning a large production run or something smaller for testing, we can help.

Additional Resources From Pathway Medtech

Want to learn more? Read more about our ISO standards for medical devices on our website, and explore the rest of our blog. You can also get additional details about the services Pathway Medtech offers as medical device contract manufacturing experts.

Contact us today and let us help you with your next project. Our medical device supply chain management team is here to answer any questions you may have about medical device packaging design. We look forward to hearing from you!