For years, Nectar has been meeting and exceeding the requirements necessary to meet the ISO 13485 standards, but today we are excited to announce that we have become one of the few companies who officially hold an ISO 13485 certified Quality Management System.
When it comes to the medical device industry, safety, and quality are essential; that’s why ISO 13485 is so important. This internationally agreed upon standard sets out very precise requirements for quality management systems to companies who are involved in the design, production, installation and servicing of medical devices. While many product development companies operate to ISO 13485 standards, obtaining official documentation requires rigorous internal audits; their completion demonstrates to regulators that a company has wholly dedicated their operation to the process of ensuring that their products are safe, reliable, and meet the highest quality standards.
The products Nectar makes must be trusted to improve, and sometimes even save, user’s lives. Thus their creation must be finely tuned, requiring tedious and detailed assessment. An ISO 13485 certified QMS is proven to support this undertaking, allowing companies like Nectar to organize and track every single variable in the creation of such sophisticated and novel devices. As a client and a consumer, you can rest assured that Nectar is achieving the most prestigious standards possible in the global market.
Given the immense quality responsibility, one might think that the rigidity of ISO standards could impose boundaries on the creativity and inventiveness that feeds innovation. There have been recent updates to ISO 13485, however that lend more flexibility from the company to address specific needs per individual product. For example, the QMS can support the ability to cater products based on specific regional requirements or on a country by country basis. The specificity of the system allows Nectar to identify the necessary revisions and design products to minimize the cost impact of these changes. This allows for the final product to be more flexible in the global market and maximizes its potential.
The financial benefits associated with hiring a company who uses an ISO 13485 certified QMS can be further captured by its impact on funding. Banks and investors often look to see if a company is registered with ISO 13485 to confirm their reliability. The association assures those who are providing capital funding that the firm designing the proposed product is reputable and that they can contribute to its success and profitability. If you’re looking to get your project off the ground, it’s wise to choose a design firm that can offer this type of incentive.
Nectar is proud to be able to offer these high-quality design, production, and manufacturing standards for our clients, and through their companies, for patients and care providers at large. If you would like to learn more about how Nectar’s ISO 13485 certified QMS can impact the development of your product, please contact us today.