ISO 13485: Frequently Asked Questions Answered

ISO 13485Recent news that the US Food and Drug Administration (FDA) will use ISO 13485 as the basis for its quality system legislation for medical devices was well received by those in the industry, perhaps none more than the ISO (International Organization for Standardization) itself. ISO 13485 is the international standard for quality management systems (QMS) that establish requirements for regulatory purposes for the medical device sector. The regulation is designed and intended to function with other management systems around the world, and by doing so, work more efficiently and transparently with each other. The move by the FDA is intended to help streamline regulatory processes for medical devices around the world.

 

The FDA’s decision to use ISO 13485 will also help the standard gain further recognition. By replacing the current quality system regulation, the FDA is taking an important step in the recognition that ISO 13485 has already gained globally. The convergence of medical device regulatory processes has been a goal of ISO for decades. The standard is already the foundation for the Medical Devices Single Audit Program (MDSAP) that is currently used by Australia, Brazil, Canada, Japan, and the USA.

As the impact of the FDA adopting ISO 13485 to replace its current regulatory system for quality management has begun to sink in, questions concerning QMS by medical device manufacturers, companies, and organizations have been steadily growing. Below is an FAQ primer in anticipation of the changes:

Why should medical device companies have a quality management system (QMS)?

The practice of implementing a QMS is a long-term strategic decision that, once in place, works to guide your company or organization to consistently meet standards, improve overall performance, and to provide a sound basis for sustainable development initiatives. A QMS also gives assurances and confidence to customers that the most stringent requirements for quality have been met.

What is an ISO 13485 Quality Management System?

Implementing a QMS for ISO 13485 follows a set of conformance requirements and interrelated processes, including any guidelines that establish, implement, and maintain the provisions outlined in the requirements of the standard with the aim of meeting customer and applicable regulatory requirements for businesses operating in the medical device sector.

What are the requirements for ISO 13485 compliance?

For medical device companies to be ISO 13485 compliant, they must have a QMS that demonstrates an ability to provide medical devices and related services that meet applicable regulatory requirements and customer approval. This standard applies to any company or organization that is involved with any one or more stages of the life-cycle of a medical device. This can include design and development, production, manufacturing, packaging, storage and distribution, installation, or servicing of a medical device or provision of associated activities such as technical support, supply chains, or product related consulting services.

Are there testing requirements for ISO 13485?

There are no testing requirements, but there are standards that must be met. Because ISO 13485 is considered a stand-alone set of quality management requirements, manufacturers of medical devices and related support and service organizations must provide documented evidence that their devices will meet safety and quality standards and perform as intended for patients or consumers. Testing of a particular product is part of the overall QMS which companies implement to meet the numerous requirements of various regulations and standards.

Does Biomedical Polymers, Inc., adhere to ISO 13485?

BMP is a global manufacturer of plastic medical devices that are used in research and medical diagnostic laboratories. As an Original Equipment Manufacturer (OEM) of medical devices, adherence to ISO 13485 has been critical to its success. BMP implemented a QMS that met the requirements of certification for ISO 13485 in 2016. Today, it provides design and engineering consultation, coordinates tooling fabrication and mold parts to specification and meets production with a state-of-the-art plastic injection molding and injection blow molding equipment all under the auspices of ISO 13485.

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Plastic Products Catalog

BMP Medical is a quality manufacturer of plastic consumables and plastic products for research and medical diagnostic laboratories. Our products are manufactured to the highest quality standards. We offer a wide selection of products sold through the world’s premier laboratory distributors.

Non-Sterile and Sterile Centrifuge Bottles

  • Available with standard caps for low-speed work and sealing caps for high-speed applications
  • Caps have a built-in gripper to facilitate removal from the rotor
  • Extra thick walls for durability-resistant to most chemicals
  • Wide mouth design makes filling and decanting easier
These precision molded centrifuge bottles are available in polycarbonate or polypropylene. For low speed applications the bottles provide excellent value for large volume/large batch centrifugation procedures. For high-speed work, the easy-to-use Noryl® (Noryl® is a registered trademark of General Electric Company) sealing caps with silicone O-rings enable leak-free processing at high centrifugal forces over long durations. Bottles must be filled to 80% of capacity. Centrifuge bottles may be autoclaved at 121ºC at 15 psi for 20 minutes. Caps should be placed on the bottles without engaging the threads. Bottles are qualified to the rated g-forces using Sorvall® (Sorvall® is a registered trademark of Kendro Laboratory Products) and Fiberlite® (Fiberlite® is a registered trademark of Piramoon Technologies Inc.) high-speed rotors, tested at 20ºC, with bottles filled to 80% of capacity. Failure to use the correct rotor cushion or adapter will shorten the life of the bottle and may prevent achievement of the maximum rated RCF and/or bottle failure. Prolonged autoclaving and reuse may cause stress cracks, crazing or bottle discoloration.
centrifuge bottle
Sterile Centrifuge Bottles 
 
centrifuge bottle
Non-sterile Centrifuge Bottles

Cytology Funnels Category

BMP Medical Cytology Funnels for the Shandon CytoSpin® Centrifuge BMP Medical Cytology Funnels are the functional equivalent of the Thermo Shandon CytoFunnel®. Fully compatible with the Shandon CytoSpin Centrifuge, BMP Medical Cytology Funnels can be used to deposit a thin layer of cells in a clearly defined area of a microscope slide. The filter card absorbs any excess fluid. Operation is identical to those supplied by Shandon and easy-to-follow instructions are included in each pack. All products sold in case quantities only.


 

metal cytology funnel clip

Metal Cytology
Funnel Clips

Double Cytology Funnels

Double Cytology Funnels

Single Cytology Funnels

Single Cytology Funnels

Hemodrop Blood Dispenser

The Hemodrop is designed to reduce the risk of exposure to bloodborne pathogens in the Hematology laboratory. To prepare a manual differential smear, a drop of blood needs to be dispensed onto a glass slide from the specimen tube. Simply puncture the rubber stopper with the Hemodrop, and then invert and press gently onto the slide. A single drop of blood will be dispensed and the slide is ready. No more removing the stopper and manually putting a drop on the slide to test blood.  
hemodrop
Hemodrop

Multipurpose Containers

These high-quality non-graduated lab containers are designed for the collection, transport, and storage of specimens and samples. Tight fitting lids prevent leaks and odors. Ideal for storing biologically hazardous samples for terminal autoclaving before disposal. Molded from various materials. The stackable containers are resistant to freezing and boiling.


centrifuge
Translucent Multipurpose
Containers

Polypropylene Beakers

Resistant to most commonly used laboratory reagents, including a variety of strong acids, bases, and organic solvents, these high quality polypropylene beakers are the premier choice for scientific laboratory applications. All beakers are transparent for clear content visibility and graduated for easily estimating volumes. Molded-in pouring spouts, and a rolled lip, for a dripless working environment. Autoclavable to 121ºC ( 248ºF).
centrifuge
Polypropylene Beaker

Specimen Collection

For specimen collection and transport, this system provides disposable products for the convenient collection, delivery, and testing of urine specimens. A plastic cup is provided for specimen collection and the pressure sensitive patient identification labels have ample writing space. The lightweight transport rack is small and easy to carry yet provides space for up to 20 tubes with labels and caps. The tubes are made of sturdy polystyrene and are safe for centrifuging. The flared top permits the use of a midget urinometer ensuring a tight cap fit. 

centrifuge

Commode Specimen
Collection Systems

urine container

24 Hour Urine Containers

urine container

24 Hour Urine Containers with Spout

Tissue & Ultra Tissue Grinders

We offer two lines of tissue grinders for the clinical lab and research lab. The standard product is all plastic and is designed to grind softer tissues such as liver and spleen. The Ultra tissue grinder line has a vitrified tip and is designed for tougher material such as muscle or bone. Both lines are delivered sterile sealed Tyvek® (Tyvek® is a registered trademark of DuPont) package.

tissue grinder

Tissue Grinders

ultra tissue grinder

Ultra Tissue
Grinders

Urine Sedimentation System

BMP Medical, a manufacturer of diagnostic products, has a full line of urinalysis disposables. We offer the components separately, or in various kit sizes and configurations. The line is built around our 10-chambered Decislide which is made out of optically clear acrylic. It can take 10 individual samples on the same slide eliminating the need for a new slide for each sample.

 

Urine Sedimentation

Urine Sedimentation
System