Most medical manufacturing companies know that quality is key. At ProMed, quality is our main driver and is an integral part of every process we undertake. Our quality professionals work hand-in-hand with our manufacturing teams to ensure quality is part of every decision we make. We provide OEMs a reliable and dependable process that yields consistent results. Consistent quality is hard work and requires rigorous, on-going monitoring of every process from purchasing to manufacturing to distribution. But the effort and focus on quality is well worth the reward. Our robust quality control and quality assurance programs ensure uniform, high-quality medical devices, and are one of the reasons ProMed stands out from the competition. Click here to watch a short video about our Quality Management System.
What is a QMS for Medical Manufacturing Companies?
Medical manufacturing companies utilize a Quality Management System, QMS, to manage their quality program. A QMS is a formal system that documents processes, procedures, and responsibilities that pertain to quality. This system addresses the design, production, labeling, distribution, storage, and other aspects related to medical component manufacturing. Medical manufacturing companies utilize the QMS to demonstrate compliance with customer requirements and regulatory regulations from the U.S. FDA as well as standards like ISO 13485.
There are many benefits of a robust QMS program. In addition to meeting the customer and regulatory specifications, a strong QMS often leads to more efficient operations, less waste, and fewer errors – resulting in a lower cost medical component.
Most highly-regulated sectors, like healthcare, require a QMS as part of the product development and registration process. The complexity of the QMS may vary depending on the classification and risk of the medical component. For example, an implantable medical device will typically have more stringent QMS requirements than a single-use medical instrument.
Looking for a medical manufacturing company that consistently delivers high-quality products?
Contact the ProMed team today to discuss our liquid injection molding solutions and our unwavering commitment to quality.
QMS Statistics about Medical Manufacturing Companies
An industry benchmark was recently conducted to test the health of quality management across the medical device industry. Below are 4 surprising QMS statistics about medical manufacturing companies. Based on these statistics and findings, it is clearly important that OEMs partner with a medical manufacturing company, like ProMed, that is truly committed to quality and embeds quality in every aspect of medical manufacturing.
- Over two-thirds of medical manufacturing companies surveyed indicated quality is woven into the company culture. The majority of medical manufacturing companies no longer view QMS programs as a “tick the box” activity but as an opportunity to distinguish themselves from the competition.
- Responsiveness is a key aspect of any robust QMS program. However, 71% of professionals surveyed indicate the data collected by their quality system is not easily accessible in real-time. It is important that medical manufacturing companies take advantage of new technologies, such as the Internet of Things (IoT) and Industry 4.0, to improve connectivity and enable real-time access to information.
- Most QMS programs are managed electronically with tools ranging from Excel to purpose-built QMS tools. About half of the survey respondents indicate they use general-purpose tools and over 80 percent noted they are asked to “make do” with legacy QMS tools and solutions.
- Most days, 3 medical manufacturing companies receive a letter indicating their medical device or component did not meet the requisite QMS standards. It is crucial that OEMs understand the QMS requirements for their specific medical component in order to remain in compliance with FDA and other standards.
ProMed’s Commitment to Quality
At ProMed, quality is not just a department, it is a cultural commitment. We understand the importance of quality to your success. That is why quality is embraced every step of the way to create a product that will assure confidence in your products.
Partnering with an experienced injection molder like ProMed allows for the necessary production planning needed to meet all of the necessary regulatory, quality, and commercial standards. Our work force is highly specialized in the manufacturing and quality requirements of medical products, much of which go into the long-term implantable market space. Every employee at ProMed is trained with the idea that quality is their most important responsibility.
Our equipment utilizes cost-effective, high-end molding technology to keep operating expenses down while producing parts with an extremely high level of precision and repeatability. Our tools are designed and manufactured to exacting tolerances. Expert toolmakers use high-tech design software and machining centers to produce molds that are durable and dimensionally repeatable from cavity-to-cavity, part-to-part!
We are an approved, certified supplier to many of the top medical device manufacturers in the world. All ProMed facilities go through routine audits by our ISO registrars and customers. Below is a sample of the standards we meet. Additionally, our products are wholly synthetic, not animal derived, and do not contain substances of very high concern or materials sourced from conflict regions.
- ISO:13485 – 2016 certified
- ISO:17025 certified
- FDA 21 CFR 820, 210/211 and part 4 compliant
- ISO Class 7 Clean Room
- REACH and ROHS compliant