Medical device package design and development is used to develop packaging that will protect medical devices during transportation, storage, and handling until they are used by healthcare professionals or patients.
Effective packaging safeguards sterility, ensures compliance, and protects your medical device from manufacturing to end use. As part of our end-to-end solutions, we design and validate packaging to meet strict FDA and ISO standards—helping you avoid costly delays and recalls. See how our tailored approach supports your product’s success.
The medical device packaging design, testing, and validation process can be intricate and time-consuming, facing intense regulatory scrutiny and often being the largest cause of FDA recalls. Starting medical device packaging validation too late in the design process can create significant challenges for most new product launches.
The process typically includes:
Developing proper packaging is important because it provides sterility assurance, supports product integrity, meets regulatory standards, and builds customer trust.
Medical device manufacturers, healthcare providers, regulatory bodies, and third-party sterilization providers all require medical device package design and development for ensure products are safe and compliant, are properly packaged and sterile, and meet public health and safety guidelines.
Life Science Outsourcing medical device packaging capabilities
LSO offers the following medical device contract assembly and packaging processes:
Medical device package testing and development can have several steps:
Requirement analysis
Requirement analysis is performed to better understand the product, device specifications, intended sterilization method, and regulatory requirements.
Material selection
Choosing the right material takes into consideration barrier properties, compatibility with the chosen sterilization method, and biocompatibility to verify that the materials are safe and non-toxic.
Design and prototyping
The design phase is to create packaging design, including consideration for ease of use. Prototypes are developed to visualize and test the design.
Testing and validation
Testing and validation are conducted to verify performance and compliance. These can include physical tests, seal integrity tests, sterility tests, and accelerated aging tests.
Regulatory compliance
Meeting standards and regulations is a critical part of the development process. Documentation is established with the design process, materials used, testing results, and compliance. Then regulatory submissions are conducted with the required documentation to regulatory bodies.
Production and quality control
The packaging is then manufactured, transitioning from initial prototype to full-scale production. Stringent quality control processes will monitor the medical device packaging production.
Labeling and instructions
Labeling is created to meet all regulatory requirements such as device identification, sterilization method, expiration date, and instructions for use.
Distribution and post-market surveillance
Distribution planning and post-market monitoring are established to manage ongoing safety and effectiveness.
Today’s FDA and ISO regulations mandate numerous protocols and test reports to validate that a sterile medical device package effectively safeguards its contents and maintains sterility throughout manufacturing, storage, distribution, and aseptic transfer to the end-user. These complex package validation regulations can lead to compliance challenges, recalls, and in the worst cases, patient harm.
ISO 11607-1:2019 and ISO 11607-2: 2019 specify requirements for packaging materials, systems, and processes to ensure sterility is maintained throughout the shelf life of a product.
Life Science Outsourcing is a medical device contract manufacturer, packager, and sterilization provider for Class II and Class III sterile medical devices, catering to both small and large OEMs.
Life Science Outsourcing’s medical device contract manufacturing and packaging services include:
Intelligent design
Our smart sterile package design approach begins with understanding which package formats ensure the required levels of cleanliness and sterility. We strike a balance between protection, ease of use, and material costs.
Virtual package visuals
We provide photorealistic renderings that are indistinguishable from the real product, offering a faster alternative to physical prototypes.
Rapid prototyping
Life Science Outsourcing employs rapid prototyping processes and quick-change thermoforming equipment.
Usability feedback
Our sterile field experts ensure that package contents can be aseptically transferred into the sterile field, in compliance with ISO 11607 and FDA regulations.
Carton design
We minimize material and transportation costs while verifying your entire packaging system, including cartons, maintains sterility during distribution and storage in accordance with ISO 11607 regulations.
DHR-Ready Sterile Packaging Validation Protocols and Reports: We supply all the unique protocols and reports for your packaging validation, tailored for your technical and regulatory files.
Simulated Distribution Testing
To save time, money, and potential headaches, we collaborate closely with accredited package testing labs for final sterile packaging validation testing. We conduct internal feasibility tests before performing a simulated distribution study, guaranteeing the package passes the test on the first attempt.
Shelf life stability studies
We design and execute studies that adhere to ISO guidelines for stability and shelf life in the shortest possible timeframe.
Our processes are designed for modularization, allowing us to produce our own tooling swiftly when needed.
Comprehensive packages for regulatory compliance.
From fractional to full cycles with EtO residual testing.
Secure with 2X qualification.
Tailored to your sterilization needs.
Life Science Outsourcing is an FDA registered and ISO 13485 certified full service Medical Device Contract Manufacturer.
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