Medical devices can literally change lives. Those who develop medical devices are looking to fundamentally change the world for the better, and regulatory bodies work to ensure that the vision of a healthier world with safe medical devices can be a reality.
That said, regulatory compliance for medical devices can be a complicated undertaking. Meeting FDA standards, ISO standards, and/or IEC standards is a large, potentially overwhelming process, but it is an imperative consideration if you’re looking to develop and manufacture a marketable medical device.
Navigating regulation: a Complex Process
When you’ve developed a medical device and are ready to apply for regulatory approval, you may find yourself initially overwhelmed. How do you prepare for this process? What happens during an audit, and how can you be ready? What happens if you don’t pass?
The short answer to these questions is that for the medical device development process you must consider regulatory requirements in even the earliest stages of your process. The way forward is to gather information, tap into existing expertise and knowledge, and use regulatory standards as benchmarks for device development.
Working with experts can streamline the process
Finding external experts to help you meet regulatory standards can help streamline the medical device regulatory process. There are distinct advantages to finding a partner who knows regulatory standards inside and out, and who can provide solutions, templates, and secure information storage to simplify and standardize all steps in the regulatory process.
Occam Design is one such expert, with experienced professionals who can act as an in-house Director of Regulatory Processes. We ensure you’re prepared for the whole regulatory process, from initial steps to post-market audits.
FDA Compliance: No Small Feat
US Food and Drug Administration (FDA) regulations cover both the safety and function of medical devices and their manufacturing processes. Fully understanding the regulatory process and developing a working relationship with the FDA early on in medical device development can help you ensure compliance throughout your process.
The steps of the FDA regulatory process include:
- Device discovery and concept
- Preclinical research and prototyping
- Testing for approval
- FDA review
- FDA post-market safety monitoring
The FDA classifies medical devices based on their use and their risk level. Within those classifications, each has specific registration steps and requirements to fulfill before your device can be approved. When it comes to the classification of your prospective medical device, gathering the knowledge you need, or working with an expert who is well-versed in the FDA process, is a highly important part of the FDA regulatory process.
As you go through the regulatory process, you’ll likely encounter snags that mean revisions and resubmissions are required. While these can seem daunting, staying organized and flexible, with a willingness to review your work and change when necessary, will equip you to navigate this process more effectively.
It’s important to know that the regulatory process does not end at device approval. After a device is approved, the FDA regularly performs audits to ensure ongoing compliance. Having external expert assistance or in-house knowledge of and responsiveness to FDA regulations is a requirement for any medical device manufacturer.
ISO 13485 Compliance: Standardization is Key
The International Organization for Standardization, or ISO, is an NGO that puts forth a set of standards, including medical device standards, that reflect the safety and quality standards agreed upon by multiple countries.
ISO 13485 standards are familiar and accepted by many countries, so while the ISO is not a regulatory body, meeting ISO 13485 standards signals to regulatory bodies in multiple countries your ability to meet safety and quality standards for your medical device. These standards can be considered broadly representative of safety standards in each individual country, though there may be additional regulatory requirements on a country-by-country basis.
IEC 60601 Standards: Safety First
Alongside FDA and ISO compliance, the International Electrotechnical Commission has developed the IEC 60601 standards to cover electrical safety for medical devices.
Similar to ISO standards, the IEC 60601 standards are established to allow for consistent quality and safety on an international scale. With IEC 60601 standards, one of the most important considerations to understand is the existence of collateral standards and particular standards. Properly written, these standards allow manufacturers to bypass or override IEC 60601 standards.
Occam Design are the regulatory experts you need
Occam Design’s in-depth expertise in medical device regulations comes directly from our work in designing and manufacturing medical devices. We are ISO 13485:2016 certified and have expertise in IEC 60601 standards. Additionally, we are registered with the FDA as a medical device manufacturer and have worked through FDA regulatory processes with multiple medical devices.
Our hands-on experience and years on the cutting edge of regulatory changes give us thorough top-down knowledge of the entire regulatory and standards-meeting process for multiple governing bodies.
If you’re looking for experts in ensuring regulatory compliance for your medical device design, look no further than Occam Design. Contact us today for a free project analysis.
Occam Design is an innovative leader in medical device design, prototyping, manufacturing, and rollout. Our team has over 30 years of experience developing and manufacturing medical devices, giving us the expertise and experience needed to make your medical device concept a regulatory-compliant reality.