Company Background:
With decades of metal finishing experience and a deep technical knowledge of the trade, in 1989 Gregg Burzynski started AeroDynamics, LLC, a premier metal finishing business. After many years Gregg brought on his wife Cara Burzynski in 2007 to join the company as President.
As of 2024 AeroDynamics had doubled its employee base. They also doubled their customer base earning work from customers like Raytheon, Gillette and SpaceX.
AeroDynamics is located in a 40,000 square foot facility in Seabrook, New Hampshire and has 40 employees. They specialize in metal finishing for the aerospace, military, and defense industries, and also serve a customer base in the commercial, industrial, and medical device fields.
Situation:
“After the pandemic manufacturing slowed down. So we were looking for ways to diversify and appeal to different industries,” said Emerson Bilodeau, Director of Quality and Engineering at AeroDynamics. “We were already in the aerospace market, but it dipped like everything else. So we decided to go after the medical market thinking it would be a good fit for us.” But to do that AeroDynamics realized they needed to go after ISO 13485:2016 certification.
Solution:
Emerson had worked with NH MEP in the past with various training opportunities they offered. In this case he reached out to an NH MEP representative for help with ISO 13485:2016 certification training. NH MEP then brought in Exolytic their 3rd party provider partner to deliver the ISO 13485:2016 certification training to AeroDynamics.
AeroDynamics pursued ISO 13485:2016 certification to establish a quality management system based on ISO 13485:2016, which included a process improvement component. AeroDynamics’ pursuit for ISO 13485:2016 certification was based on the company’s strategy to train its employees on best quality management practices and position the company to compete globally, while satisfying the requirements of the medical device industry.
AeroDynamics trained 9 employees to create a documented system with ISO 13485:2016 as the basis for registration at their facility. Existing quality system documentation was used where possible in the training for the creation of the new system. Upon creation of the documentation, AeroDynamics was assisted in implementing ISO 13485:2016.
Results:
“It had been a bit of a slow start for us to get new medical device work. Sometimes it takes a few years,” said Bilodeau. “But in the meantime we have been able to support some of our existing customers better. That is because ISO 13485:2016 certification opened up some of our accounts that had medical device work we otherwise would not have gotten.”
The following results for AeroDynamics, LLC can be credited to having gone through ISO 13485:2016 certification:
- New sales of $5,000 over the last 12 months that otherwise would have been lost
- Retained sales of $100,000 over the last 12 months that otherwise would have been lost
- Retained 1 new job over the last 12 months
- $6,000 cost savings in labor, materials energy, overhead or other areas over the last 12 months
- Increased investment of $25,000 in plant or equipment over the last 12 months
- Increased investment of $5,000 in information systems and software over the last 12 months
- Increased investment of $7,000 in workforce practices or employee skills over the last 12 month
“NHMEP was instrumental in helping us implement the ISO 13485 quality management system. They connected us with Exolytic whose expertise guided us through the process, identifying gaps, optimizing documentation, and training our team. Thanks to their support, we achieved ISO 13485 certification efficiently, improved our processes, and enhanced product quality and customer satisfaction. NHMEP has been a vital resource in supporting our ongoing continuous improvement efforts, helping us maintain high standards and drive long-term success.”
