- Does the FDA certify coatings?
- Does UL or NSF certify coatings?
- Are there specific tests that qualify a coating for medical end use?
- What other tests or methods qualify a coating for medical end uses?
- How can a medical device manufacturer get a coating approved?
- Do you have any biocompatibility testing performed on your coatings?
- Does SSG have any coatings for devices used for implantation in the human body, such as arthroscopic implants?
- Our designers have strict masking requirements. Can SSG provide repeatable and accurate masking?
- What temperatures are our parts subjected to during the coating process?
- How does your staff understand how important a job is to us, the customer?
- How do you assure coating thickness is correct?
- How do you measure electrical resistivity, static bleed, conductivity, insulation and other electrical requirements?
- Will your coatings provide finished dimensions required on our blueprints?
- Are you ISO approved?
- Do you have a quality manual?
- Can we conduct a quality audit at your facility?
- What quality standard do you meet?
Does the FDA certify coatings?
No, the US Government or any agency does not directly certify any coating. However, several avenues for independent certification exist, such as actual biocompatibility testing performed by independent test laboratories. Several levels of testing are available.
Does UL or NSF certify coatings?
No, each end use is specifically investigated by the agencies and if a coating is part of the design, the coating can be accepted but only as far as this single design submission.
Are there specific tests that qualify a coating for medical end use?
Yes, one example is ISO certification standards such as 10993-1 for short-term contact with the human body. Another test is ISO 11070: 1998 (e) for mechanical testing of coatings on coated guidewires.
What other tests or methods qualify a coating for medical end uses?
For decades, several types of coatings have been successfully used to coat guidewires, cannulas, probes, etc. An example is ISO 11070: 1998 (e) test that has been used to qualify coated guidewires. History and specific tests has created a “body of knowledge” as to which coatings have been used without any negative results. SSG has all of these coatings in stock. SSG cannot and will not directly certify any coating for any end use.
How can a medical device manufacturer get a coating approved?
SSG can provide a list of laboratories that will perform the appropriate tests to provide the manufacturer with the data.
Do you have any biocompatibility testing performed on your coatings?
As of the first quarter, 2009, we are having two series of SSG formulated coatings independently tested for ISO 10993-1 and other appropriate testing for medical devices for short-term contact or less than 24 hours in the human body. This will allow our customers to potentially reduce the time it takes the manufacturer to qualify a device for a medical end use. Please contact SSG for updates as to test results.
Does SSG have any coatings for devices used for implantation in the human body, such as arthroscopic implants?
No, furthermore, SSG will not consider any coating application for long-term residence in the body. This is a decision more related to the legal climate rather than the strength of modern coatings and the decision by the Board of Directors of SSG.
Our designers have strict masking requirements. Can SSG provide repeatable and accurate masking?
Yes, our seasoned team has dozens of devices and techniques to mask per your requirements. We realize repeatability is a mandatory requirement and have proven techniques and materials to provide precision masking. Additionally, our team may suggest methods to provide your designers with the results they need without the additional costs of masking. Allow us to provide our recommendation as to alternatives to masking.
What temperatures are our parts subjected to during the coating process?
This depends on the specific coating. Many of our medical applications are catalyzed or are two-part resins that require room temperature or UV cure (no substrate temperature). We will provide cure temperature during the Solutioneering Form coating analysis for your specific job. The maximum temperature of processing is 750f for many medical grade coatings.
How does your staff understand how important a job is to us, the customer?
We involve every staff member in a Gainsharing program. Our affiliate, Orion Industries Ltd., has pioneered this type of management and fiscal sharing program. Every production team member receives a monthly check, which is related to perfect quality for each and every job, meeting delivery dates, employee attendance, shop cleanliness, and several other measurables, which our management considers extremely important. Any SSG staff member can stop a job at any stage of production with no negative consequences.
How do you assure coating thickness is correct?
We have developed many non-destructive tests. Each dimensional job is pre-measured in incoming quality testing to establish the statistics related to the specific job. In the shop, many devices like laser micrometers, scales, jigs, CCD cameras, CCD micrometers, digital microscopes with micron accuracy measurement software and a combination of innovative devices to help assure the coating thickness is correct. In most cases, the final cure of the coating is performed after all coating thickness measurements have been verified.
How do you measure electrical resistivity, static bleed, conductivity, insulation and other electrical requirements?
Electrical testing can be influenced by many factors. It is essential that your engineers coordinate and compare specific equipment specifications for comparable testing. We have Hi-Pot, Holiday, wet bulb testing, saline sponge testers, resistivity testers, Valley Lab endoscopy current generators and more devices to measure coating electrical requirements.
Will your coatings provide finished dimensions required on our blueprints?
Yes, to achieve a go-no-go or a precise, not-to-exceed coated dimension, we need to coordinate a measurement procedure with your staff. We recommend both SSG and our customer use the exact same measurement device. Then, we will absolutely guarantee that the coated parts meet a specific dimension.
Are you ISO approved?
Yes, we are compliant to ISO 13485:2016.
Do you have a quality manual?
Yes, we do have a quality manual, and our Q.C. manager will be happy to meet with you to discuss the manual and our procedures.
Can we conduct a quality audit at your facility?
Yes, you can conduct a quality audit at our facility. We have many each calendar year. Please call our Quality Control Manager to set up an appointment at (773) 427-2084 x128
What quality standard do you meet?
Our quality control program is based on Mil-I-45208A, Mil-STD-45662, C=0 Sample Plan.