Our Quality

Our Quality Commitment

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.

Every employee at ProMed is trained with the idea that quality is their most important responsibility. We believe employees are our greatest asset and a critical element to maintaining our excellent quality record. We encourage employee development and growth, assuring each team member has the skill sets necessary to meet and exceed your expectations. Everyone at ProMed participates in our Continuous Improvement programs, making and implementing suggestions for small ways to make the company better. Collectively, all the small things will have a large impact on the overall success of the organization.

Regulatory & Compliance

The materials in our products are wholly synthetic, not animal derived, and do not contain REACH or ROHS restricted materials, Substances of Very High Concern (SVHC), or materials sourced from conflict regions. ProMed hereby certifies that our products are REACH and ROHS compliant, free of BSE/TSE, and contain no materials from conflict regions.

Our Policy

ProMed is committed to the manufacturing and testing of quality products and serving the needs of our customers by providing products and services (including laboratory) which:

  • Consistently conform to customer and regulatory requirements (including but not limited to the ISO 13485 international standards).
  • Are priced to provide superior value and are delivered on-time

The management team is committed to continually improving the effectiveness of the Quality Management System, ensuring that all personnel are competent and qualified for the tasks they perform, and that all personnel familiarize themselves with quality system documentation in order to implement the policies and procedures in their work. These standards of service ensure our products consistently meet our high quality standards.

Our Quality Processes

ProMed Quality Assurance is dedicated to delivering silicone and thermoplastic components, devices, assemblies and combination pharmaceutical device products of the highest quality. To ensure that components consistently meet quality standards and comply with federal regulations, a robust quality system was developed. Our development engineers partner with you and provide feedback to optimize key features that will yield a highly capable manufacturing process. We develop and validate every process to ensure its repeatability. After product release, we maintain strict process controls using a continuous improvement program that ensures success for years to come.

ISO Registration and FDA Compliance

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, demonstrating our robust quality system that is ISO 13485:2016 certified, FDA 21 CFR 820, 210/211, and part 4 compliant.

Quality at ProMed is an integral part of our manufacturing process and company culture.

Lean Six Sigma

Partnering with ProMed means partnering with a company devoted to continuous improvement through Lean and Six Sigma methodologies. ProMed monitors product and process performance during the development and production phases of manufacturing by incorporating Six Sigma quality management principles using the DMAIC process to drive continuous improvement.

ProMed Molded Products has been on its Lean journey for nearly a decade, centering on the simple concept that every employee is empowered to make a difference. Our manufacturing group is made up of several small teams which operate as self-managed business units. These teams are responsible for meeting quality, delivery, and cost goals. Each team member has been given authority, even to the extent that he/she can stop a production line if needed. This team culture has given ProMed the flexibility to grow rapidly without adding unnecessary layers of management.

To assure our success, ProMed has hired and trained certified Lean Six Sigma Black Belts. We have also established an extensive library of reading material and ProMed specific lessons that are made available to all its employees. This collection of materials is what we call “ProMed University”.
Additionally, we have a Lean Six Sigma Green Belt certification program which trains on Lean principles and the DMAIC thought process. We explore the tools used within DMAIC and provide a solid foundation of statistical concepts and project management.

Even with a top down commitment, and both the education and statistical tools in place; the entire workforce must be engaged to maximize success. At ProMed, we are drawing people in through a Lean game. The entire organization participates from manufacturing to the owner. Teams are created and tasked with making the company better in some small way; with the thought that collectively, all the small things will have a large impact on the overall success of the organization. An idea is called a Continuous Improvement (CI) and each month, the team having the most CI’s implemented receives a small prize and trophy to display at their work stations for the month. We have found that the various teams enjoy the competition that goes along with the game concept, but we are mainly driven by the idea that we all have an impact on ProMed’s future success.

The core idea is to maximize customer value while minimizing waste. From manufacturing teams to the ProMed’s president, we drive improvement from every aspect of the organization. The game has fostered a re-energized work force that demonstrates ProMed’s commitment to its customers, its employees and to the industry. With employee involvement comes improvement opportunities that are addressed at the source.

Continuous Improvement

Our Certs