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Quality

Expertise rating: 697

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reviews hfacqe found useful

Lince Consulting - Consulting


R & D / Engineering , Medical Device
02/26/2014

Speed 2 / Price 1 / Quality 1

We worked with Lince consultants on a new innovative product. We needed to get to market quickly and efficiently due to time and budgetary constraints. I was not impressed at all by their services. The regulatory path that they recommended was not typical of what I was accustomed to.

They also provided Quality services that at times seemed strange and unprofessional. I am not sure but we were provided document templates that seemed to be used by other customers.

I was glad that we decided to go another route and switch to a different counsulting agency.

Strengths: offers cunsulting services in Regulatory, Clinical and Quality

Needs to improve: Could improve providing more value for services

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Merrill's Packaging Inc - Mediocre At Best


Quality , Medical Device
02/22/2016

Speed 2 / Price 2 / Quality 2

We used Merril's once to design a tray for one of our devices. The did a terrible job with the design of the tooling. The trays they supplied us had cracks and breaks in multiple places. They wanted us to pay for upgrades to the tooling that they designed. As soon as we are going to qualify another vendor to produce our trays.

Strengths: They were close by

Needs to improve: Terrible customer service and poor engoineering work.

Exponent, Inc - Simply the best at what they do


Quality , Medical Device
02/22/2016

Speed 5 / Price 3 / Quality 5

When I contact Exponent, something very bad has happened that involves a potential recall. They are very responsive. in the past, they have been at our facility hours after calling them and when they arrive, they are adding value from the very beginning helping us plan and strategize the investigation and failure analysis. The last time I called them, we experienced a failure on our 2 year real time aging samples and through testing and analysis, they were able to conclude that the failure was not age related, They drew on the expertise of several of their scientists with different backgrounds to be able to reach that conclusion. In the end they provided us with a report that we would have no problem presenting to the FDA or any other auditor.

Strengths: All of their scientists are at the top of their field and they have at their disposal the most advanced testing and analytical capabilities. They are extremely customer focused and will do what ever it takes to meet a deadline.

Needs to improve: None

Kelcourt Plastics Inc - Excellent supplier of medical grade plastics


Quality , Medical Device
04/21/2014

Speed 5 / Price 5 / Quality 5

None

Strengths: Custom Product, Customer Service, Fast Setup, Great Product, Never Dissapointed With Items Shipped., On Time, Quality Product, Quality System, Quick Turnaround, Reliable Service , Wide Selection

Needs to improve: Excellent vendor to look for stock materials of items. The prices are extremely affordable and the quality is great. Their customer service has always been good and very responsive and helpful.

A&B Die Casting - High quality aluminum castings


Quality , Medical Device
03/31/2014

Speed 5 / Price 5 / Quality 5

I have worked with A&B on several occasions for aluminum castings and I have always been pleased with their work. They have quick turnaround for prototypes and are very cost effective. When ever a problem comes up in receiving inspection, their quality group is very quick to respond.

Strengths: High quality aluminum die casting, capable engineering staff, good customer service and very responsive quality assurance group.

Needs to improve: None

Thermo Fisher Scientific - High commitment to quality and customer service


Quality , Medical Device
03/31/2014

Speed 5 / Price 5 / Quality 5

In a previous company, we manufactured proprietary cry equipment for aesthetic medicine. We used a chiller from Thermo Fisher as the chilling source. The chillers were very reliable, we hardly ever had any field issues. When a problem did come up, their quality group worked very closely with us to determine root cause and implement corrective actions. I was very impressed with their customer service and commitment to quality.

Strengths: Thermo Fisher makes a very wide variety of laboratory equipment. immersion and recirculating chillers, centerfuges and cold storage. They have excellent customer service and a very responsive quality control department.

Needs to improve: None

Chatillon - Excellent mid-range force testers.


Quality , Medical Device
03/31/2014

Speed 4 / Price 5 / Quality 5

I absolutely love Chatillon force testers. They are compact easy to use and very reliable. We have been using Chatillon force testers for the last 8 years and the only thing we have had to do was calibration. It never once went down. They have a very limited selection of fixtures so we have had to custom make several in our machine shop which was not that difficult. The software is powerful and very user friendly. We also use several hand held force testers on the production floor for 100% screening. As with the table top systems, very easy to use and very reliable.

Strengths: Chatillon makes very high quality mid range force testers. the systems are very reliable, economical and are small enough to fit in tight spaces. This really is a great alternative to Instron or MTS when you need a small easy to use system. The Chatilon software is very user friendly and their have a very helpful and knowledgeable technical support staff.

Needs to improve: Not very big on fixturing, you need to a lot of it custom made.

Tinius Olsen Testing Machine - Very high quality material testing equipment


Quality , Medical Device
03/31/2014

Speed 3 / Price 3 / Quality 5

We have Tinius testing equipment on the production floor. We use the Model H1K-S UTM force tester for destructive testing. The machine was easy to install, validate and implement. The software is very user friendly, I like it much better than Instron's Blue Hill. The only issue we have is the annual calibration which can be very costly. On a few occasions, we needed an emergency calibration at it was very costly to get them out in 24 hours.

Strengths: High quality materials testing machine for a wide variety of tests including compression, tension, impact, hardness, torsion. They have excellent customer service and sales support and the equipment is very reasonably priced with the respect to their competitors.

Needs to improve: Calibration services are expensive and usually has long lead times unless you by a very high expedite fee.

British Standards Institution - The best and most respected notified body in the world.


Quality , Medical Device
03/30/2014

Speed 5 / Price 5 / Quality 5

BSI is a very tough but fair notified body. We have been using them for three years and I really feel that our facility benefits tremendously from every audit. During the audits, I feel that they are not there just to find problems but to help find solutions to fix the problems as well. As our notified body, they also provide CE marking for our products. We always use their dedicated review service. While it costs more to use, it is a way to significantly cut down on the approval time. I think hands down, BSI is the best notified body.

Strengths: BSI is the among the most respected ISO-13485 notified body in the world.

Needs to improve: More expensive than other notified bodies.

DQS GMBH - Mediocre notified body services


Quality , Medical Device
03/30/2014

Speed 3 / Price 4 / Quality 2

When we were a small startup, we used DQS as our notified body. They were cheaper than the others and had very easy audits. We were really happy with DQS and then we got acquired by a major company who used BSI and eventually, we had to convert over to BSI. That's when we realized that DQS was a worthless notified body. BSI was an entirely different situation. In the first audit with BSI, they uncovered so many quality system issues that had never been detected by DQS.

Strengths: DQS provides ISO-13485 audit and certification services. They are in expensive and very easy to pass their audits.

Needs to improve: DQS is an extremely easy notified body. They are practically a rubber stamp. We used them for about 5 years before switching to BSI and they were terrible auditors. At the end of the audit, no matter what they found, we always got a certificate and maybe a few recommendations.

Cleanroom Services & Investigation (CSI) - Reliable cleanroom inspection services


Quality , Medical Device
03/30/2014

Speed 5 / Price 5 / Quality 5

We depend on CSI to ensure compliance to all relevant regulatory requirements. Every month, CSI conducts inspections to ensure the cleanroom airflow systems, air quality systems, and differential pressure systems are functioning properly. They provide us with meticulous records that have never had any problems in ISO and FDA audits.

Strengths: CSI provides outstanding cleanroom services including inspection, testing and certification. Periodic inspections and audits from CSI ensures compliance to IEST-RP-CC006.3, ISO-14644-1 and FDA requirements.

Needs to improve: None

Servicor Modular Cleanrooms - A very good turnkey modular cleanroom solution


Quality , Medical Device
03/30/2014

Speed 3 / Price 4 / Quality 5

We needed a modular cleanroom constructed in our warehouse and took in several quotes. We liked their design and quote, the only problem was that they had to give us a start date 5 weeks out. We still went with them and we were not disappointed. The cleanroom had everything needed to meet a class 1,000 cleanroom and easily passed FDA inspection.

Strengths: Servicor provides portable modular cleanrooms. They come in and set up a complete turnkey cleanroom including all of the airflow systems and meters.

Needs to improve: Long waiting time to get the work started.

Prudential Cleanroom Services - Reliable cleanroom garment services


Quality , Medical Device
03/30/2014

Speed 5 / Price 4 / Quality 5

We only had a very good experience with Prudential. They handle all of our cleanroom gowning needs, both reusable and disposable gowns. They come every week and ensure that we always have clean gowns and ensure that our storage cabinets are always stocked with disposable cleanroom garments. They also provide all the cleaning supplies for the cleanroom as well.

Strengths: Prudential provides very reliable cleanroom garment processing services and cleanroom cleaning products. They are very cost effective and have excellent customer service. They have processing plants and are able service facilities all over the US.

Needs to improve: None

Us Linen & Uniform - Excellent uniform services in the Pacific Northwest


Quality , Medical Device
03/30/2014

Speed 5 / Price 5 / Quality 5

When I was working in Spokane a few years back, US Linen provided all of our clean room gowns. They had excellent service, every two weeks they would drop off clean gowns and pick up dirty gowns for cleaning. They also use to supply us with disposable gowns, booties and hair nets. Every time they came, they made sure our cabinets were well stocked. They ware also very cost effective. Too bad they only service the Pacific Northwest.

Strengths: Us Linen provides uniform services in the Pacific Northwest. They provide both re-usable uniforms which are picked up and cleaned and disposable gowns, booties and hair nets. They are very cost effective and reliable.

Needs to improve: None

PeelMaster Medical Packaging - High quality cost effetive medical device pouches


Quality , Medical Device
03/30/2014

Speed 3 / Price 3 / Quality 4

Peelmaster is one of our approved sources for pouches and die cut cards. The Tyvek pouches are very durable, high quality and cost effective. Our pouches come with a really nice thumb notch that our customers really like. We have never had any sterile barrier issues with Peelmaster pouches.


Strengths: High quality medical device pouches, header bags and die cut cards. The pouches can come with many different options such as: peelable or non-peelable, thumb notch, track seals and hanger holes.

Needs to improve: High production lead times and slow to give quotes

ClearBags - High quality cost effective industrial polyethylene zip bags


Quality , Medical Device
03/30/2014

Speed 5 / Price 5 / Quality 5

We use clearbags zip lock polyethylene zip bags in the R&D lab to contain small components, and in the kan-ban bins in production. The bags are very durable and have a section that allows for labeling with a felt pen. They come in different colors which is great for part segregation.

Strengths: Clearbags makes boxes and packing materials. Their products include clear polyethylene zip bags in thicknesses from 2 to 6 mils in many sizes and configurations. The bags are high quality and very cost effective.

Needs to improve: None

AGS (Prev Atlas Box & Crating) - Reliable crating services


Quality , Medical Device
03/30/2014

Speed 5 / Price 3 / Quality 5

At a previous company, we used to manufacture and ship very large and heavy medical equipment all over the world. Atlas would send packing personnel to crate our equipment at our facility. They did an excellent job and the crates and packing materials kept the equipment safe. They were always on time and very efficient. We never had any shipping related damage. The services were very expensive, but well worth it.

Strengths: Atlas Box & Crating manufactures wood and resin pallets, reusable crates, wood boxes. They also provide crating services on site if needed. Additionally, they make a wide variety of products to secure and protect products during transportation.

Needs to improve: On site crating services are very expensive. Otherwise, their process are very competitive.

Xpedx - High quality packing materials


Quality , Medical Device
03/30/2014

Speed 5 / Price 5 / Quality 5

We use Xpedx boxes and packing materials in our warehouse and we have never had any problems. Their double wall boxes are durable and impact resistant. We have never had any problems with any of the products we get from Xpedx. Additionally, they are very cost effective. We never had a chance to use their custom products but given the quality of the off the shelf products, I am sure they would do good job.

Strengths: Xpedx is a great resource for packaging supplies. They make corrugated cardboard boxes, shrink wrap and impact protection materials like foam and bubble wrap. In addition to their extensive off the shelf offerings, they have an in house packaging engineering team to design custom packaging to meet specific needs.

Needs to improve: None

Uline - Uline is a great source for warehouse and janitorial products


Quality , Medical Device
03/30/2014

Speed 5 / Price 5 / Quality 5

We use Uline products all over our facility. In the warehouse we use Uline boxes, carts, labels and bubble wrap. The carts have many uses in our manufacturing floor and receiving inspection lab. The cleaning staff uses the janitorial supplies such as gloves, mops brooms and buckets. The best thing about U-line is that its a one stop shopping resource and very cost effective.

Strengths: Uline is a great source for warehouse products such as boxes, carts, bubble wrap and janitorial supplies, tape and tags.

Needs to improve: None

Mean Well USA Inc - High quality switching power supplies


Quality , Medical Device
03/30/2014

Speed 5 / Price 3 / Quality 5

We have incorporated the PSD-45 into our instrument. The power supply provides a 2:1 wide input range, built in EMI filter and free air cooling. Our biggest worry was IEC-60601 compliance but this was never a problem, we had no issues with EMI interference. The technical support engineers were very helpful in working with us to select the right power supply for our application. The supplies are expensive but well work the cost.

Strengths: Mean Well makes very high quality switching power supplies. They make stand alone, on board, PCB and enclosed systems. The systems are reliable, energy efficient and easy to implement into most designs.

Needs to improve: Very expensive

The Raymond Corporation - Reliable forklifts and paller trucks


Quality , Medical Device
03/30/2014

Speed 4 / Price 3 / Quality 5

We have a Raymond forklift in our finished goods and receiving warehouses. The lifts are easy to operate, stable, reliable and very maneuverable. We also have several pallet trucks to move pallets around the facility. The forklifts are reliable and easy to maintain. We have never had any problems with Raymond equipment.

Strengths: Raymond makes fork lifts and pallet trucks. The products are reliable, easy to use and come in a variety of sizes to fit any size warehouse.

Needs to improve: Costly

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