Precision Concepts has been a major part of the medical industry for decades. We fill our ISO certified and FDA registered facilities with experienced professionals to ensure that the final results meet all your expectations and industry regulations.
We provide complete assembly of medical and electro-mechanical devices as well as a full range of engineering, prototyping, stamping, and molding services. Along with our in-house manufacturing services Precision Concepts offers full supply chain management and sterilization management
Our team is never content with just delivering a product, though. Our business revolves around building long-term partnerships. This means teaming you with the most experienced experts to transfer your production line, produce and assemble a full range of products, and get the superior quality, price, and lead-time that your company needs in a competitive market.
Talented, Experienced, and Dedicated Engineers
The Precision Concepts team of engineers specializes in new product development, project management, and cost-saving solutions via DFM.
We currently employ 35 engineers with multiple disciplinary backgrounds, ranging from mechanical and electrical to industrial and design engineers. Our whole team can work together to ensure the highest levels of production quality and line transfers in a complete engineering solution.
We use the latest software analysis to simulate manufacturing environments, and our skilled team can provide:
- Tooling and fixturing
- Risk analysis
- Project management
We have people on staff who are trained and experienced with several project transfers, and since everyone here is trained on the same methodology (PMI methodology) we are able to work together to deliver the best possible results.
Each of our operators has been cross-trained on every process we offer. They bring, on average, 12 to 14 years of experience to the table, and they are ready to take care of any soldering, welding, and fusing operations. You name it, and they’ve been trained in it.
This is critical to the production process, and even more so for a line transfer. Traditionally, a line transfer could require 5 or 6 weeks of training. In those cases, the operators would go to the site to be trained on the process.
Since our elite operators have extensive cross training, they show up on the site with all the work instructions and skills they need. This allows us to get up and running in just a week or two.
We have even had cases where our operators have more experience with the processes than the people on site. And, when potential issues come up, they are able to work closely with our engineers to solve or minimize potential issues.
Working with the Costa Rica Facility
We also have a location in Costa Rica that houses multiple ISO Class 8 clean rooms in our 70,000 square-foot facility. The facility is ISO 13485:2016 and ISO 9001:2015 certified, and FDA registered, which is how we are able to maintain such a high standard of quality while still delivering exceptional value.
Many companies have already transferred their entire production lines to our Costa Rica facility in order to achieve notable cost savings.
Insuring the Highest Quality Through Effective Planning Methods
Precision Concepts Group uses Advanced Product Quality planning methodology to ensure that your requirements and expectations are met or exceeded.
We want you to be fully confident in our processes and performance. This is why we perform thorough process validations through the IQ, OQ, and PQ stages following the specific protocols you have provided or we have developed for you.
We take this commitment to quality a step further, though, and have integrated our own information systems into our Quality System Dashboard. This allows us to gather all the necessary information and use it to provide quicker responses to any internal needs or changing customer requirements.
Our advanced methodology includes level 3 Production Part Approval Process (PPAP), which makes use of:
- Process flow and control diagrams
- Process FMEA
- Material certifications and specifications
- Risk and sterilization management
- Regulatory compliance
- Process validations
- Controlled environment management
Making Testing and Inspection a Foundational Part of the Process
Our QC department is a critical part of this process, right along with our engineers and operators. This is where we implement the process validation, controlled environment management, and much more to ensure that your products are manufactured to the highest standards.
For example, our stamping tolerances are maintained with well-engineered, close-tolerance tooling. We take it a step further, though, by using inspection cameras that can detect profile or formed defects. This allows us to provide 100% inspection of critical part features.
Precision Concepts always operates according to the guidelines that we have established in our quality policy. And that means we are always striving to deliver the value, service, and quality that you need and expect.