What do you manufacture? If the answer is “medical devices” then the path is clear: yes, you need an ISO 13485 contract manufacturer. You might not be “required” based on some regulatory loopholes, but why would you ever want to take the risk?
What’s ISO 13485?
ISO 13485 is one of the most important standards for medical device designers and manufacturers. This standard defines a broad range of requirements on quality management system (QMS) for medical devices and equipment. ISO 13485 registered manufacturers are subject to periodic audits mandated by the ISO governing body to ensure continued compliance and recertification as the standards evolve.
The medical device and equipment industry and major standards organizations have come together to define standards on quality management systems (QMS) for ensuring quality in product design, as well as for auditing the reliability of their manufacturing process.
ISO 13485 company specifies requirements for organizations involved in one or more stages of the medical device life cycle. ISO 13485 assembly expands on the QMS fundamentals defined in ISO 9001. Among the list of requirements in Medical device Contract Manufacturer, device designers, engineering services firms, and manufacturers must comply with a list of documentation, management, design and development, traceability, auditing, testing, sterilization, and other production requirements.
ISO 13485 is an extension of the quality and continuous improvement standards specified in ISO 9001, carrying greater specificity to the medical device industry.
Benefits Of Partnering With An ISO 13485 Contract Manufacturer
Medical device companies looking for a partner have many important factors to consider and finding an experienced, ISO 13485 contract manufacturer is one of the most important ones. Working with an ISO 13485 certified manufacturer gives medical OEMs greater assurance that their products will pass the rigorous quality and safety requirements specified in FDA and EU regulations.
Aside from regulatory requirements on medical devices and equipment, medical OEMs can see some important benefits when working with an ISO 13485 contract manufacturer:
- Product requirements: An ISO 13485 contract manufacturer ensures the production team, design team, and all other parties have a clear understanding of the end customer’s expectations and the product’s required functionality. This helps the design and production team prevent common errors that can arise during production and ultimately ensures user safety.
- Auditing and transparency: Any QMS should carry some level of transparency, both for auditors and even for customers. Many ISO 13485 manufacturers are willing to share audit outcomes with customers, showing they can be held fully accountable for product quality and safety.
- Reduced liability: Anyone that has paid attention to court settlements knows that litigation resulting from a failed piece of medical equipment can be extremely expensive. Medical OEMs can benefit from the traceability, design, and materials validation, risk assessments, and other processes implemented by a medical device contract manufacturer.
Although ISO itself does not require a contract manufacturer or other organization to seek certification under ISO 13485 or ISO 9001, some jurisdictions may require working with organizations that hold ISO 13485 certification before a medical product can be released onto the market. Working with an ISO 13485 contract manufacturer shows regulators and customers that your device was manufactured by an organization with a compliant QMS, ultimately improving your chances of passing qualification.
ISO 13485 company represents an exhaustive effort to make sure each component of a medical device meets the most rigorous safety standards.
Working With An ISO 9001/ISO 13485 Dual-Certified Contract Manufacturer
Working with such a contract manufacturer is a great way to reinforce the safety chain without lifting a finger.
Creanova Italy hold both certifications, ISO 9001 and ISO 13485, and as a dual-certified contract manufacturer, we can help you navigate both standards on your next medical device.
As an ISO 13485 contract manufacturer, we’ve implemented a traceability and auditing system as part of our QMS, ensuring your next medical device will carry the documentation required to satisfy regulatory requirements.
As part of our comprehensive QMS, we track inputs and outputs in each manufacturing operation for every technician in our facility.
The traceability, design verification, materials validation, supplier controls, documentation (clear, transparent information), risk assessments, competent workforce, and other benefits are assured and are an indispensable and integral part of operations in our company.
What if you need to manufacture a non-medical device?
By hiring a Contract Manufacturer with an ISO 13485 assembly, companies can rely on the ability of the CM to manufacture their technology to the highest standards.
If you are looking for an ISO 13485 contract manufacturer that produces and assembles your medical device, look no further than Creanova.
Creanova’s contract manufacturing services are built to the highest standards of quality and our team can support you from tooling to manufacturing – including PCB Manufacturing, Programming and Testing – up to the complete assembly.
Contact us to discover our services portfolio for MedTech companies across the globe (industrial design, development, and contract manufacturing), and let’s get your project started!