ISO 13485: 2016 and What It Means for Product Development in the Medical Field

Introducing and updating international standards has proved key in pushing companies to raise the bar in product development over the last fifty years. ISO 13485: 2016 specifically addresses the way companies implement management strategy that focuses on products that are safe and effective. The new standard requires a higher level of responsibility to be in the hands of management by laying out detailed guidelines to create a stronger quality management system (QMS).

The ISO 13485 update also includes guidelines for safety when manufacturing and testing medical devices, specifically those concerning contamination and cleanliness in the work environment. These clauses help guarantee that medical devices developed will not be compromised by by external biological variables.

Nectar Product Development (Nectar) reviewed the guidelines and realized that we not only meet but exceed the requirements necessary to meet this standard, so Nectar will soon become one of the few companies registered as ISO 13845: 2016 compliant.

With the implementation of ISO 13485: 2016, a standard that according to the International Organization for Standardization (ISO) “ensure(s) the establishment of QMS practices that consistently yield safe and effective medical devices”, clients and partners can feel reassured that the product designed by Nectar is meeting the highest standards possible in the global market.

While this standard will ensure safe and reliable products, the newest version also has a financial advantage for both customer and company. When banks or investors want to know if a company is reliable, they will be looking for one registered with ISO 13485. So, if you’re looking to get your project funded, choose a company that already has proven it can meet and maintain quality standards.

ISO 13485 also requires developers to look closely at every decision made during the process of design and development. This process includes minimizing waste during testing and development as well as improving risk management.

ISO 13485 corresponds with ISO 9001, a previously implemented standard, yet there are specific differences. The principal difference between the two is that ISO 9001 requires continual improvement. ISO 13485 requires that consistent quality standards be met and maintained. This doesn’t mean stagnancy, however. ISO 13485 allows for more flexibility from the company to address specific needs per product as well as catering certain products based on specific regional requirements on a country by country basis, while still meeting and maintaining the highest international standards. This makes the product more flexible in the global market, with only minor revisions potentially needed.

In fact, according to ISO, the intention of the newest standard is “not to impose new requirements on your organization, but to clarify existing requirements that were vague, confusing or implicit in nature to ensure common interpretation by all users”.

 

Here’s a break-down of what the new standard entails:

ISO 13485: 2016…

  • Places the responsibility of regulatory requirements on management by documenting and maintaining a Quality Management System (QMS)
  • Implements controls throughout production and testing to ensure product safety
  • Requires detailed record-keeping of the design process for data analysis
  • Enhances communication by making documents comprehensive, organized and simple to read
  • Ensures a focused approach to risk-management
  • Increases cost-efficiency by identifying any design flaws and challenges early on
  • Regulates how documentation occurs, specifically for implantable devices and sterile medical devices (such as implementing control of contaminants and creating requirements for health, clothing and cleanliness of personnel)
  • Reduces any delays in schedule and compromises in design
  • When it comes to correcting and preventing problems, there won’t be delays; establishes under what circumstances these nonconformities occur and adjusts the design for these circumstances so they don’t reoccur
  • Implements a QMS where any and all problems are imagined, planned for, and prevented
  • Evaluates and validates any changes before implementation and only after communication with all parties involved

And of course,

  • Ensures that the design, manufacture and distribution of the product is safe and effective

With the certification of this standard 13485: 2016, Nectar commits to meet the requirements necessary to prove not only their excellence in product development from start to finish, but also proves their effectiveness in management practices that actualize quality products and a sustainable, satisfactory relationship with their clients.  

If you’re looking for a company that can provide the type of quality assurance that puts you as the investor or client in a state of ease, you can be confident that any company with a certification for ISO 13485: 2016 will be a good choice. Not all companies have this certification, and some that do are given a three year transition period to meet all requirements.

Nectar has been holding itself up to these standards for a long time prior its application for certification. The practice of quality management and control is deeply ingrained in our company culture and in the way we develop our medical devices. With a closed-circuit operation where we can oversee and work closely at all levels of design and production, there are less unknown variables that might compromise quality or safety. We’re a small company with a big reach, and we invite you to check us out.

2018-09-13T17:56:07+00:00

About the Author:

Majoring in cultural anthropology from CSULB, Bryn is a freelance writer and internationally published author of educational articles, short stories, and poetry. When she isn't conducting research and writing, she is a full-time G.E.D. teacher and part-time yoga instructor. Her personal hobbies center around community building, making music, and her three huskies. If you ask her why she insists on being busy all the time, she'll respond, "Life is lovely when it is full."

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