Many precision companies design, manufacture, and distribute medical devices. However, not all of them have undergone the rigorous process to be ISO certified. Though it is not compulsory by law to be certified, it shows that the business operates and continually improves its products and processes.
When looking to work with a company, it is important to go with ISO-certified ones to reduce the risk of product defects and waste. Additionally, you can be sure of consistency in quality, better employee performance, and customer satisfaction. To make it easy, we’ve done our research and made a list of 7 best ISO 13485 certified companies you can use. Read on to find out more.
Why Choose ISO 13485 Certified Precision Manufacturers
An ISO 13485-certified company has a robust quality management system that adheres to global standards. Such a company will maximize production flow and ensure faster turnaround times. Choosing to work with an ISO 13485-certified precision manufacturer does the following for you.
Customer Satisfaction
When using ISO 13485-certified suppliers, you can be sure of customer satisfaction. Every stage of manufacturing meets quality standards which reduce the risk of recalls as a result of flaws. An ISO-certified company understands and meets every customer’s needs. End users receive consistent and high-quality medical products and services which builds a long-term relationship.
Compliance with Regulations
ISO 13485 certification shows that a company has complied with regulations and standards applicable to the medical industry. It is important to use companies that adhere to regulations to mitigate risks associated with medical device manufacturing. This helps to prevent lawsuits from patients or relatives who have been harmed as a result of manufacturing defects.
Safety and Effectiveness
ISO 13485 standards guarantee patient safety and ensure that the final parts serve their purposes. Note that this standard also contains specifications related to the manufacturing of implants and prosthetic devices. By working with a certified company, you are confident that implants and prosthetics are manufactured in a controlled room and are sterilized to prevent infection.
Better Consistency
Getting ISO certification means that a supplier is determined to meet all quality requirements to ensure consistency in production. You can’t go wrong with such a supplier because the parts produced in a batch and even across batches are accurate and closely resemble each other. Consistent and repeatable medical products drive revenue growth and enhance brand reputation.
Continuous Improvement
It pays to work with a supplier that regularly analyzes their activities and looks for ways to continuously improve their products. Such a company documents procedures and conducts regular management reviews. With this, they can identify loopholes and opportunities for improvement.
How Do I Check for ISO13485 Certified on Precision Manufacturers
Before partnering with companies or using their products, it is important to confirm that they are ISO 13485 certified. You can do this online or offline.
Online ISO 13485 Verification
To go about this,
- Visit the website of the precision manufacturer you have chosen.
- Look out for the ISO 13485 certification logo. You can get this on the section of their website that covers quality management systems.
- Check if the certification number is available online or you can download the certificate from the website.
- Go to the website of the certifying body and enter the certification number.
- With this, you can verify the details or the certification and check for the issuance and expiry dates.
- For companies that do not publicly display the certificate, you can search directly using the business name and check if it is certified.
Offline ISO 13485 Verification
For offline verification,
- Request for a copy of the certification and check for important details such as the logo, certifying body, and expiration date. Check if the certification body is verified.
- Inspect their products for quality control and check for the certification badge on both primary and secondary packaging materials.
- You can also carry out the verification process by physically visiting the business premises. You verify their quality management system and decide they meet your standards.
- You can also contact the certifying body to check the precision manufacturer’s status.
- Perform other steps that may be specific to your organization.
Best ISO13485 Certified Precision Manufacturers
Let’s look at 7 best and recommended certified precision manufacturers you can trust
#1- Zintilon
With more than 20 years of experience, Zintilon is one of the leading manufacturers of surgical equipment, diagnostic machines, and implants. Zintilon has been assessed and certified by Guardis International Certifications GmbH for complying with ISO 13485:2016 standards. The company is certified for manufacturing metal and plastic parts and assembling medical mechanical components. Zintilon’s ISO 13485 certification number is G21Q2GZ0553ROM and the date of initial certification and latest renewal date are June 1, 2021, and June 22, 2021, respectively. Zintilon uses high-end CNC machines and 3D printers and their experts vet the workpieces before delivering them to customers.
#2- RapidDirect
RapidDirect’s operations meet with the medical industry’s highest standards. This company has obtained a medical device quality management system certification. RapidDirect has a robust system that ensures that the manufacturing of hardware for medical equipment and plastic parts is in line with ISO 13485:2016. A certificate with the number 46622MD102605ROS was issued on October 21, 2022, and is said to expire after 3 years. RapidDirect is known for manufacturing surgical equipment, pacemakers, and mechanical organs.
#3- Xometry
Xometry is another precision part manufacturer you can work with. The company is ISO 13485:2016 certified which shows that their quality management system is appropriate for the manufacturing of safe medical devices. Xometry was certified on March 18, 2022, by Perry Johnson Registrars, INC with a certificate no of C2022-01242-R2. The scope of the certification covers custom manufacturing service for medical devices, utilizing advanced technology to coordinate work with a network of suppliers. It also includes in-house machining, assembly, and additive manufacturing services.
#4- Orthopedic Implant Company (OIC)
OIC is one of the top manufacturers of high-quality orthopedic implants. Their products include the proximal humerus, distal and proximal tibia, clavicle, and trochanteric retrograde nails. OIC received ISO 13485:2016 from Perry Johnson Registrars, INC on October 27, 2020. Not only does this company manufacture implants following quality standards, but OIC implants are also affordable and maybe half the average market price.
#5- BMP Medical
BMP Medical is an OEM medical device supplier. They deal mainly with plastic parts from laboratory consumables to class I medical devices. National Quality Assurance (NQA) has certified that the quality management system of BMP Medical meets ISO 13485 standards. The certificate with the number 17389 was first issued on May 26, 2015. A recertification audit was carried out and it was reissued on May 21, 2021. The scope of the certification covers the manufacturing and assembling of custom plastic products for research, medical, and clinical markets.
#6- Catcher Technology
Catcher technology is another recommended precision medical device manufacturer. They started more than 25 years ago and they focus on class I and II medical devices. Catcher technology is ISO 13485 certified with a certificate number of TW21/10520. The accreditation and certification body is SGS, United Kingdom Ltd. Catcher technology has been certified since October 28, 2021, to meet standards for the manufacturing of sterile and nonactive minimally invasive instruments for orthopedics and surgical use. The certification also covers manufacturing of nonsterile metal components for minimally invasive surgical instruments.
#7- H. Galow
The procedures and processes of H. Galow also meet international standards. This company has been producing and assembling medical components since 1961. Their quality management system was independently audited and certified on January 3, 2022, by Perry Johnson Registrars, INC to conform to ISO 13485:2016. The certification is with respect to manufacturing precision machined components and assemblies on dedicated CNC machines per customer requirements.
Conclusion
In today’s highly competitive business world, you must avoid working with random manufacturers. ISO certification is like a badge of honor, commitment, and unwavering quality. However, it extends far beyond that. After deciding on who you want to work with, you must also take a bold step by reaching out either online or conducting a physical visit. This will help you decide if the company can meet and exceed your evolving needs.
