NAMSA - Irvine Location

NAMSA is the company I go to when I’m looking to obtain a conservative pulse on the regulatory agencies. Since many of their scientists serve as advisors for the FDA, there isn’t a better person (including the FDA themselves) that can give you a clearer understanding of the environment and motivation behind new implemented standards. For example, we were recently tasked with the requirement of particulate testing. Although the idea is not new, the motivation behind it is. Since there is currently no established specification for non-injectable med devices (e.g., USP for injectables and drugs), it is possible to develop a unique specification according to our application. NAMSA was instrumental in this and took into account manufacturing, sterilization, shipping and distribution, packaging, shelf life, and use with other devices when developing the test method. In the end, our product produced particulates that met USP standards, which we could still use, but this process highlighted NAMSA’s attention to detail and dedication to their craft.

Strengths: Material Characterization, Histopathology, Biological Safety Evaluation, Particulate Analysis, Regulatory Consulting

Needs to improve: Depending on the test, expedite fees can be double or more of the actual test costs

NAMSA is known for a lot of their regulatory, R&D and post market services and consulting but we use sterilization monitoring products. they have a wide range of products to monitoring sterilization in their catalog to validate how and if our sterilization process was effective and successful, monitor that our instruments and devices are properly sterilized, and distinguish processed from unprocessed goods. their products have always given us consistent and reliable results. all of their products are extremely easy to use and require very minimal training which is great for our staff to not have too much downtime training. all of their products meet ISO regulations and guidelines. we have been very satisfied with the results we've received them NAMSA and we have used them over 50 times for our instruments

Strengths: reliable, consistent results, regulatory consulting, research and development support, post-market support, medical device expertise, medical device testing

Needs to improve: price may be higher than others in the industry

We have used NAMSA for biocompatibility and sterilization testing. When we send our devices/products here, they are able to provide us a breakdown of our products, if they are sterilized properly, if the tools that we are using in our facility are good enough. In the end, they provide a nice and concise report that gives us all the results. One thing I particularly appreciated while working with them is that in the situations that our products were not meeting sterilization guidelines, they were able to provide us suggestions on how to improve our process from our end in order to achieve the results that we were looking for. Its this type of feedback that we appreciate and the reason why we continue to use NAMSA for our entire product line.

Strengths: chemical analysis, biocompatibility, customer service

Needs to improve: None

Most of the time testing at NAMSA has gone fine. The time's it hasn't have been difficult. Often requiring us to review test procedures and records to determine if the problem was truly with our device or with the way the test was performed. Many times we found errors is the test preparation. Have since move to another lab, and no longer face these issues.

Strengths: Bio-compatibility Testing

Needs to improve: None

Great that Namsa is located in SoCal, sooner or later, medical device companies will need their service. Being in Irvine allows me or the team to drop off and discuss our needs with the Namsa experts.

Strengths: New location was exceptional customer service and response time. Lots of focus on ensuring customer satisfaction. Certainly hope this is continues and being located in SoCal allows for in person discussions.

Needs to improve: Hard to say, but the only thing that comes to mind is that it takes a long time to get final reports reviewed and approved. No different than other companies, lots of QA checks before report is released.

I have used NAMSA on many occasions for biocomaptibility testing. They have very knowldegable people there to walk you through every step of the process and explain the required testing as well as make recomendations. They give detailed instruction on how the samples are to be submitted and they provide compete GLP reports if needed. They also provided asistance for troubleshooting when a test failed.

Strengths: NAMSA is a comprehensive biocompatibility and sterilization validation resource. They have the expertise and resources to conduct all required biocompatibility testing and sterilization validation.

Needs to improve: Slow turn around and can be difficult to get on their calendar for testing.

My company contracted NAMSA for guidance concerning the medical device prototype we were developing. Our R&D department was having trouble hashing out the details of the schematics and NAMSA's consultancy proved invaluable in arriving at an effective solution. They were extremely thorough and their expert team provided insight on possible problem areas. Customer service was top notch as they maintained constant communication throughout the process. Excellent team of specialists that saved us a ton of hassle. Will definitely use them again.

Strengths: High level of industry knowledge, tailored solutions, excellent work product

Needs to improve: None

we reached out to Namsa for regulatory consulting solutions. their staff members were able to develop and implement regulatory strategies within our company. their service is efficient, responsive, and they provide very high quality service. they've also helped us to prepare submissions and manage communications with other regulatory bodies. they will provide you on-site support and provide clinical and statistical data if needed. they offer consulting assistance through ever step of the process

Strengths: regulator consulting, R&D support, non-clinical testing, clinical testing, post-market support, medical device, medical device testing

Needs to improve: none

Consider visiting in person during implantation and explantation days so that you can keep an eye on the lab staff.

Strengths: Huge organization backing up their work. Access to world experts.

Needs to improve: Maybe it was just this past time, but they really messed up my most recent biocompatibility test program. Harvesting was not handled in a professional manner and it felt like we needed to stay right on them to ensure that the work was done right.

NAMSA has provided biocompatibility testing to validate our product. I've not seen any issues after getting results. They are very professional when handling parts and performing their testing. Although the quality of the reports are great and provide everything we need for audit purposes, sometimes we've had to manage the status of the reports closely to make sure they were received on time.

Strengths: Biocomp testing, technical reports, customer service

Needs to improve: Lab reports can take a while and need to manage closely

We reached out to NAMSA as we needed guidance concerning a medical device prototype. Our R&D department was working on the schematics and NAMSA's consultancy proved invaluable. They were extremely professional and their expert staff shed insight on possible issue areas. Customer service was fantastic as they maintained constant communication throughout. Quality team of specialist that saved us a lot of headache.

Strengths: accurate quotes, turnaround time, customer service

Needs to improve: none

We used NAMSA for bio-compatibility testing and once for material analysis. Good communication on the requirements of certain testing and works well with your quality department. Can be expensive and hard to schedule, but it is worth it for the end result.

Strengths: Reliable service for Bio comparability testing and material analysis. Strong communication rep there. Accurate test reports.

Needs to improve: Expensive for expedite fee. Normal final report may take a while.

Overall we had a great experience with NAMSA. We used them for clinical testing. They did a thorough job and the report was easy to understand. They are trustworthy company with strong in-house expertise.

Strengths: We used NAMSA for clinical testing. They did a thorough job and kept us in the loop throughout the process.

Needs to improve: I wish testing process was faster, but it may not be possible.

NAMSA is an industry leader when it comes to biocompatility testing. We use them all the time for all of our medical devices and have never had an issue with them.

Strengths: Very knowledgeable. We use them for biocompatility testing. They have a quick turn around time. They are very helpful and offer suggestions if you are unsure about your results.

Needs to improve: Need to schedule appointments ahead of time

Our experience has been great with NAMSA we have not had any issues at all we often purchase our labels from them for our products and it helps us get our products in order so we know which of our products have not been tested yet.

Strengths: Labels

Needs to improve: We have not had any issues with their services

I have used NAMSA for both USP, ISO and FDA biocompatibility testing services. They are able to perform testing and provide high quality work. They give excellent advise if you are unsure of which tests are needed for your medical device including extraction solvents and extraction conditions. I would recommend them for biocompatibility testing.

Strengths: Testing Services, Testing Knowledge

Needs to improve: Cost, Turnaround Time

Easy to work with and delivers reports when promised

Strengths: Well-known company that performs a variety of testing for product submissions. They have many in-house experts that can assist you to ensure that the correct tests are being performed and that the results will be usable for filings.

Needs to improve: Certain testing can be pricey since it's set by the corporation

Our company uses NAMSA for material analysis to include bio compatibility testing. They are very knowledgeable and reliable in their results. Their service sometimes take longer than I wish. Otherwise they are a great supplier.

Strengths: Excellent services for material analysis, knowledgeable, convenient, helpful representatives

Needs to improve: Seems to sometimes take a long time for results

Full service testing house to address all requirements of ISO10993, etc. Very knowledgeable staff can offer guidance navigating applicable standards for your specific device. Getting back result time is same as other company although wish to get them sooner.

Strengths: Great biocompatibility testing company. Reliable and fast response on inquiries.

Needs to improve: None

On three occasions NAMSA has damaged samples such that new samples need to be provided. This resulted in delays and extra cost to our company. If you are a startup this can be critical.

Strengths: Biocompatibility Testing

Needs to improve: Care of Samples.