This blog is generate by Mr. Masudur Rahman
Table of Contents
Introduction
Choosing the right custom medical device packaging design is crucial for safety, compliance, and ensuring that products stay effective. Whether you’re a manufacturer, distributor, or healthcare provider, having the right packaging is important.TAKO, with over 45 years of experience, offers a range of solutions designed to keep your devices safe and sterile. If you’re ready to find out how to get the most out of your packaging, here are our top tips.
1. Identify Requirements for Custom Medical Device Packaging Design
The first step in a successful custom medical device packaging design is knowing the specific needs of your product. Medical devices have different requirements, so your packaging must match those needs closely.
Things to Consider:
- Does your product need sterile packaging for medical devices, like easy-peel pouches or cleanroom bags?
- Is your product sensitive to things like light, moisture, or dust?
- What regulations must the packaging meet to keep the product safe and compliant?
Packaging Options Available from TAKO Healthcare
| Packaging Type | Sterility Level | Best For |
| Easy Peel Pouch | High | Surgical tools |
| Easy Tear Pouch | High | Medical disposables |
| Medical Paper Pouch | High | Lightweight items |
| Cleanroom Bags | High | Implants and tubing |
| Fully Recyclable Tyvek® Pouch | High | Eco-friendly options |
Choosing the right packaging type is key to protecting your product. TAKO offers a range of custom medical device packaging designs to different needs. Not sure which one is right for you? Contact TAKO for advice.
2. Ensure Your Packaging Meets Compliance Standards
When designing custom medical device packaging, it’s important to make sure it follows all the necessary rules and regulations. This is not only about protecting the product, but also about making sure it meets standards for safe use.
Compliance Checklist
- Work with a certified packaging partner like TAKO, which meets international standards like ISO 13485 and UKAS approval.
- Make sure the packaging solutions meet ISO Class 5 cleanliness standards, which are critical for sterile packaging for medical devices.
- Ensure your packaging is validated through third-party testing to meet global regulations.
Regulatory Standards Overview
| Standard | Certification Body |
| ISO 13485 | TÜV NORD, LRQA |
| ISO 9001 | TÜV NORD |
| ISO Class 5 | UKAS |
| ISO 11607 | TÜV NORD |
| Sedex Membership | Sedex |
At TAKO, we make sure our packaging meets important standards. This means our products are safe and ready for the market. Our ISO 13485 certification shows we have a strong system for making medical devices.
With ISO 9001, we focus on keeping our customers happy and always improving. ISO Class 5 ensures we maintain clean conditions during production.
Our ISO 11607 certification helps us keep medical devices sterile in their packaging. Being part of Sedex shows our commitment to being ethical and responsible. If you want to learn more about compliant packaging, just ask our team! We’re here to help you out.
3. Optimize for Cost-Effective Packaging Solutions
Creating a good custom medical device packaging design doesn’t have to be expensive. There are many ways to keep costs down while still ensuring quality and compliance. TAKO offers a variety of cost-effective medical device packaging solutions.
Ways to Save Costs:
- Choose recyclable materials like Tyvek® that are affordable and meet sterilization standards.
- Bulk purchase packaging materials to lower costs per unit.
- Work with a local partner like TAKO to reduce transport and import fees.
TAKO’s custom medical device packaging designs are made to be budget-friendly without compromising on quality.
4. Keep Your Packaging Sterile and Safe
Sterility is essential in custom medical device packaging design. The right packaging should keep your device safe from contamination, ensuring it remains effective and ready for use. TAKO’s products are designed to maintain sterility throughout the lifecycle of the device.
Best Practices for Sterility
- Select packaging materials that are compatible with sterilization methods, like Gamma or EtO.
- Use TAKO’s cleanroom bags and easy-peel pouches, which are made in Class 100 cleanroom facilities to prevent contamination.
- Choose materials that have high barrier properties to block contaminants.
TAKO’s packaging solutions are made with sterility as a priority, ensuring your products remain safe and secure. Contact TAKO to find the best option for your devices.
5. Choose Functional and Durable Custom Medical Device Packaging Design
Key Requirements to Follow
- Material Selection
- Choose materials that meet regulatory requirements and are suitable for sterilization.
- Testing Methods
- Conduct rigorous testing to ensure the packaging maintains sterility.
- Documentation
- Maintain thorough documentation to demonstrate compliance with industry standards.
TAKO’s 5 Certifications: Enhancing Credibility in Medical Device Packaging Standards
An effective custom medical device packaging design should be easy to handle and durable enough to protect the product during storage and transport. TAKO focuses on making packaging that not only keeps the product safe but also provides ease of use.
Design Tips
- Select easy-tear or easy-peel features for quick access to the product, reducing the time needed to open packages during emergencies.
- Use medical paper pouches and cleanroom bags for lightweight items that need protection but easy handling.
TAKO’s designs aim to combine safety and ease of use.
Bonus Tip: Think About Eco-Friendly Packaging
Choosing sustainable options for your custom medical device packaging design helps reduce environmental impact while still meeting all safety and compliance standards.
Eco-Friendly Options
- Use TAKO’s Fully Recyclable Tyvek® Pouch for a sustainable yet safe packaging solution.
- Opt for monomaterial options that are easy to recycle and meet the requirements for sterile packaging for medical devices.
TAKO’s eco-friendly packaging options support your company’s green initiatives while maintaining safety and compliance. Interested in sustainable packaging? Talk to TAKO to explore our eco-friendly packaging solutions.
Conclusion
The right custom medical device packaging design is all about understanding your product’s needs, following compliance rules, keeping costs low, ensuring sterility, and choosing functional designs.TAKO has been providing trusted solutions since 1979 and can help you find the best fit for your devices. Ready to start? Contact TAKO today for a free consultation and find the perfect packaging for your medical devices.
What is the packaging standard for medical devices?
The packaging standard for medical devices is mainly defined by ISO 11607, which ensures that packaging maintains the sterility and integrity of the devices.
How do you package medical equipment?
Package medical equipment by choosing protective materials, ensuring sterilization, labeling clearly, sealing securely, and testing for integrity. At TAKO, we provide customized packaging solutions for your needs.
Is it cost-effective to make custom medical device packaging?
Yes, custom medical device packaging can be cost-effective. It reduces waste, ensures compliance, and protects products, leading to savings on production and transportation costs.
Disclaimer:
The information on this blog is not a substitute for professional advice. While TAKO will exert reasonable efforts to ensure that the information contained on this page is accurate and reliable, it does not warrant its completeness, suitability, or applicability to any specific business or regulatory requirement. For specific advice on your business or industry, consult with us immediately.
