Understanding ISO 13485, ISO 11607 and FDA 510(k) to get to market faster

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Understanding ISO and FDA requirements graphic

A truckload of statutes, standards and benchmarks govern the way medical devices are designed, manufactured, packaged and marketed. Medical device companies bringing new products to market will be familiar with these three which are specifically important:

ISO 13485 – The most widely accepted quality management system criteria that companies, including contract manufacturers, must meet if they serve the medical device industry.

ISO 11607 – It specifies the requirements and testing methods for materials, preformed sterile barrier systems, sterile barrier systems and packaging systems; this information is essential to earning FDA clearance to market a product.

FDA 510(k) – Documentation submitted to the U.S. Food and Drug Administration that demonstrates a new product is similar enough to a prior-approved predicate that the lengthy Premarket Approval process is unnecessary.

Below, we illustrate how processes are streamlined and time to market is compressed when a turnkey manufacturing outsourcing partner is engaged in the hard work of meeting these requirements.

The FDA 510(k) submission matters most, so we’ll start there.

Don’t let FDA 510(k) be a bottleneck

Gaining FDA clearance to market a new medical device via the 510(k) submission process is much-preferred compared to the Premarket Approval process.

If you’re under pressure to get to market fast, and the product you’ve developed is substantially similar to a product already cleared by the FDA, you could earn 510(k) clearance in as little as 90 days.

On the flip side, it could take much longer if

Documents compiled in the 510(k) submission demonstrate that your company follows the Good Manufacturing Practices (GMP) as defined in federal law (21 CFR part 820). Aspects of GMPs include:

  • Adequate design and manufacturing controls
  • Supplier management procedures
  • A way to receive and investigate complaints

To earn clearance as quickly as possible, it’s imperative that you collect and organize all the information the FDA needs to see to make a speedy ruling. Among the documents the FDA requires are data showing the package design will work for the shelf life required, the process to manufacture the packaging is reliable and the sterilization process is validated.

In our experience, small or midsize device companies are sometimes taken by surprise here. Often, they initiate the submission process before solidifying a packaging and sterilization plan. The potential bottleneck that emerges here can set timelines back by several weeks — an amount of time no company can afford to lose.

Engaging an outsourcing partner earlier in program development will give you greater awareness of what the 510(k) process requires. Choosing a turnkey provider can accelerate the process because they coordinate the myriad tests the results of which are required as part of the submission.

Learn about J-Pac Medical’s turnkey approach here.

(Note: While the GMP requirements under FDA 510(k) mention the ISO 13485 standard — and even though the FDA in 2018 stated its intent to use 13485 as the basis for amended quality systems legislation — the two today remain separate and their distinction is important to understand.) 

Developing processes that meet ISO 13485

ISO 13485 covers much of the same ground as the FDA does in its GMP rules. And while the former standard is voluntary in the U.S., it might as well be a prerequisite here for all the importance that device companies place on their suppliers and contract manufacturers in being certified.

If you intend to market products for export to Europe in addition to domestic sales, ISO 13485 is legally required by the European Union.

The certification goes a bit further in its requirements than the FDA, assessing the structures and systems that impact how a company is managed. For one example, to earn the certification companies must show that they have strong resource allocation abilities. For another, certified companies must prove they have mechanisms in place to receive and investigate complaints and identify corrective actions.

Also, ISO 13485’s requirements pertaining to the validation of manufacturing and packaging processes for which verification is destructive or too expensive are stricter than what FDA mandates.

(As an aside, note how interconnected all these requirements are: Validation is also a hallmark aspect of the ISO 11607 standard described below; the results of testing conducted in the pursuit of meeting ISO 11607 requirements are instrumental to earning clearance from the FDA.)

Importantly, ISO 13485 tells us what is required but gives no guidance on how to achieve it. Same goes for the FDA. That being the case, the how falls on device companies and their outsourcing partners.

In the case of small- to medium-size device companies that require added guidance from outsourcing partners to launch new products, it’s imperative that their partners can develop quality procedures that comply with both FDA and ISO requirements at once.

Navigating the complexities of ISO 11607

If the FDA 510(k) submission is the most important documentation generated in your medical device development program, then the ISO 11607 standard is the most complex.

Consider that the 11607 standard is over 50 pages long and references an additional 100 standards within its text. It’s hard enough to grasp that the Association for the Advancement of Medical Instrumentation (AAMI) saw fit to publish a technical report providing guidance on interpreting the standard. That guidance is twice as long as the standard itself.

Boiled down, companies developing processes in compliance with the standard must show:

  • How a product is designed
  • That the way the product is manufactured and packaged will work
  • Test results proving the products will survive transport
  • Test results proving the product meets stated shelf-life requirements

In our experience, medical device companies underestimate the complexity of meeting ISO 11607 requirements.

In fact, around 30% of all device packages fail their validation test.

Obviously, companies under pressure to launch products on aggressive timelines shouldn’t accept only a 70% chance of success. A turnkey manufacturing outsourcing partner with the right knowledge and capabilities in place will know what it takes to pass inspection every time.

A summary of J-Pac Medical’s suite of packaging development and testing capabilities illustrates the point:

  • Established knowledge and existing networks of available raw material sources
  • Biocompatibility testing to guarantee a good match between selected packaging materials and manufacturing equipment and processes for sterilized products
  • In-house tooling, thermoforming and photorealistic rendering to aid in prototyping
  • In-house verification testing to predict future formal test results or anticipate potential failures and develop corrective action

All told, bringing all this under one roof can shave as much as two months off your launch timeline.

Another key benefit that relates specifically to meeting ISO 11607 criteria is that your product might be a candidate for pre-validated packaging.

Once your product design is solidified, good manufacturing outsourcing partners should determine whether the product can be packaged using materials and processes that have already faced scrutiny under ISO 11607 criteria.

In our view, there’s no need to reinvent the wheel. If we don’t have to, we won’t, and the timeline to launch your product can be further reduced by several weeks.

Reduce risk and commercialize faster with turnkey outsourcing solutions

Medical device companies know they need to meet the many requirements that govern the development of the innovative products they create. But actually bringing these innovations into the world can be daunting.

It is J-Pac Medical’s mission to own the process with turnkey assembly, packaging and sterilization solutions that meet regulatory muster so you can deliver these essential products to clinicians and patients without delay.

If you’re staring at the regulations and standards and wondering how you’ll get it all done on a tight timeline, we might be the partner you’re looking for. Contact J-Pac now.