Medical Device Manufacturing Certifications

Searching for quality products that meet all relevant certification and compliance standards? Look no further!

Remington Medical answers your frequently asked questions about medical device manufacturing certifications and standards to help you choose the right contract manufacturer.

What Is the ISO 13485 Medical Manufacturing Certification and International Guidelines?

The medical manufacturing certification, ISO 13485, is an international standard that demonstrates requirements for a quality management system specific to the medical device manufacturing industry.

The international guidelines state that medical device manufacturing companies must meet the following requirements to obtain an ISO 13485 medical manufacturing certification:

Maintain product safety by implementing work environment controls.
Perform proper risk management and design controls during new product development activities.
Demonstrate compliance to mandatory regulatory requirements in their jurisdiction, such as US FDA 21 CFR, part 820 requirements and the European Union 93/42/EEC directive.
Meet requirements pertaining to specialized cases, such as traceability for implant devices, process validation for medical device sterilization, and proper management of Corrective And Preventive Actions (CAPA).

If a medical device manufacturer is ISO 13485 certified, they’ve proven that their manufacturing process for medical devices meets the above requirements while adhering to a broad set of guidelines related to:

Documenting manufacturing processes
Implementing steps for medical device product development
Incorporating basic medical device safety standards into their procedures

What Are FDA Medical Device Regulations?

All FDA approved and cleared medical devices intended for use in the United States are generally required to register annually with the FDA by the manufacturer or distributor. Every device that’s marketed in the U.S. is grouped into three classifications by the FDA to determine regulatory requirements:

Class I
Class II
Class III

Class I Medical Devices

Class I devices present the least amount of risk to the patient, so they’re exempt from certain FDA requirements, like 510(k) (premarket notification) and PMA (premarket approval).

FDA Class I medical device classification covers a wide variety of devices, including:

Tongue depressors
Oxygen masks
Reusable surgical scalpels

Class II Medical Devices

Class II devices offer more complications than Class I. Because of the increased risk they pose for patients, Class II devices’ design, manufacturing, testing, and labeling standards are stricter than Class I devices. Marketing of Class II devices in the U.S. requires clearance under FDA’s premarket notification and (510(k) processes. However, certain Class II devices may be exempt.

Examples of Class II medical devices include:

Intravascular catheters
Blood transfusion kits
Syringes

Class III Medical Devices

Class III devices include many complex, high-tech instruments, like smart medical tools, life support systems, and other invasive, high risk devices. Devices grouped into the classification III category are typically required to undergo the strictest assessments and evaluations compared to Class I and II devices.

Examples of Class III devices include:

High-frequency ventilators
Pacemakers
Defibrillators

Medical Device Manufacturing Certifications_

What Are the EU MDR Changes?

The European Medical Device Regulation (EU MDR) changes are a replacement set of standards from the previous Medical Device Directive, or MDD. In most cases, the new requirements bring the EU medical device manufacturing regulations up to date with the above U.S. FDA medical device classification standards.

What Is a Medical Device Manufacturer of Record?

A medical device manufacturer of record is who the FDA considers to be the product owner. It’s common for multiple companies and suppliers to be involved in the product development process, so it’s important for the FDA to know who to hold accountable for the device if questions arise during the approval process. However, the FDA requires all contract manufacturers and sterilizers of finished devices to register and list regardless of whether they put the device into commercial distribution or returned the device to the manufacturer or specification developer.

What medical device manufacturing certifications does Remington have? Check out our other FAQ page to learn more.

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What Is Product Transfer for Medical Devices?

Product transfer for medical devices refers to the process of moving a device’s final production when a single-source supplier can’t perform tooling, molding, assembly, or complete contract manufacturing services.

There are various reasons for medical device OEMs to consider a production transfer for the manufacturing or assembly of a medical device:

To boost capacity
To optimize costs
To improve capabilities
To relocate services closer to customers or component suppliers

Our Medical Device Quality Standard

At Remington, we know that standards and requirements are constantly changing and improving in the medical device manufacturing industry—but we never falter. Our team is committed to adapting quickly and efficiently to FDA and ISO standard improvements that ensure quality medical devices make their way to the market. Contact us today to learn more about medical device manufacturing certifications and standards.