Medical Device Validation and Verification Requirements

Medical Markets Working in Lab | Medical Device Process ValidationOriginal Equipment Manufacturers (OEM) of medical devices must perform and pass FDA approved medical device process validation and verification before any product can be introduced on the market. In the medical device industry, process validation and verification is a term that indicates that a product, service or other outcome has been subjected to such scrutiny that the result of the process can be practically guaranteed. This is significantly important not only to satisfy FDA requirements for public health and safety but to ensure business success. Processing deficiencies may only be revealed through process validation and verification. 

What is the validation process?

Validation of a process involves demonstrating that a product will consistently produce and comply with predetermined requirements as defined in its design and development. It is defined by the FDA as “confirmation of a product by examination and provision of objective evidence that the particular requirements for a specific intended use can be consistently fulfilled.” Process validation is designed to establish by “objective evidence that a process consistently produces a result or product meeting its predetermined specifications.” FDA regulations state that verification is defined as “confirmation by examination and provision of objective evidence that specified requirements have been fulfilled.”

These are necessary steps to ensure that all medical devices meet regulatory standards for the health and well-being of the public. No doubt that the wide range of challenges that OEM’s of medical devices encounter in manufacturing specific products is immense. Medical devices are manufactured by OEM’s whose size, structure, management methods, production capacity, and assembly lines can vary substantially. Production and assembly, i.e., the number of manufacturing steps per unit (e.g. adhesives or soldering steps) will considerably influence how process validation and verification will be applied.

What products need to be verified?

Technologies and applications must vary to meet the challenges above. Medical devices range from small hand tools to complex computer-controlled surgical equipment; from implantable pins, rods, screws, and plates to artificial limbs and organs. Something as minor as blood-glucose testing strips to major diagnostic imaging systems such as X-ray and ultrasound, computed tomography (CT), magnetic resonance imaging (MRI), and nuclear or positron emission tomography (PET)—even laboratory test equipment—must go through the regulatory process.

The completion of process validation is a regulatory requirement that a manufacturer must adhere to. It is best to start the validation and verification process as early as possible and choose the right validation expert to guide your product through the required steps. Properly controlled design and development activities can reduce the length of time to market for new products.

Are there compliance protocols in place?

In general, to meet compliance and award approval, manufacturers should follow three protocols with the overall objective to formulate a plan to: obtain data, record data, and interpret data. The process begins with the installation qualification (IQ) protocol. Whereby, an initial qualification of the equipment used and provision of necessary services are met. The second step is the operational qualification (OQ) protocol to demonstrate that the process will produce acceptable results, test limits and establish process parameters. The third phase is the performance qualification (PQ) protocol. This step should be designed to establish long-term process stability.

In sum, OEM’s are legally obligated to meet the requirements for process validation and verification as established by FDA regulations. Understanding how to perform process validation is therefore vital to a company’s success. Compliance in performing process validation will help ensure a predictable and predetermined outcome, reduce the time it takes to get a medical device to the market, help reduce costs, and successfully complete process validation and verification of your product to receive FDA approval.

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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