Posts tagged "Requirements"

cGMP – Medical Equipment Calibration – How it affect our success – ISO 13485:2016

June 17th, 2019 Posted by e-GMP, Requirements Management, Validation and Verification 0 thoughts on “cGMP – Medical Equipment Calibration – How it affect our success – ISO 13485:2016”

Calibration is considered as an essential procedure for any equipment and device, in order to maintain and improve its accuracy and precision. Calibration is the process, in which equipment under test is compared with some other standard equipment, in order to understand the accuracy of the one being produced. The calibration of medical equipment is also based on the same principle.

Medical equipment calibration is essential to the success of the product, the demand for calibration planning system is increasing, owing to various factors, such as rising number of hospitals, increasing environmental regulations, and rising customer focus towards quality and precision. The purpose of this article is to help identify both the current and future of calibration in the medical device market.

Medical device calibration has two sections, the service types, and the equipment types. The equipment types have a market in the following segments;

 

  • Infusion pumps
  • Fetal monitors
  • Ventilators
  • Imaging equipment
  • Vital sign monitors
  • Cardiovascular monitors etc.

 

Meanwhile, the service types have three major markets namely;

  • In-house Calibration: The Professional personnel of the company will perform the calibration. The staffs are mainly from the production line.
  • Third Party Calibration Services: Other professionals outside the company will perform the calibration for a fee.
  • OEM Calibration Services: The owner of the service will need to set up plans and notification ahead of time.

 

Out of the all above devices, The medical device producers of imaging equipment requires calibration services are the largest demand. Although, there are expectations that cardiovascular monitors will keep growing at the highest growth rate to match demands.

Increasing focus of customers on the quality, rising growing need for more control on the calibration planning and documentation due to strict compliance environment which are key factors expected to drive the growth of this demand.

The critical factors in driving the demands for cardiovascular monitors include:

  1. Customers are focusing on quality.
  2. The need to control calibration planning.
  3. Strict compliance requires documentation.
  4. A rise in product recall.

 

Reports from the FDA in the US show that in the past decade, product recalls has grown from 763 to 3202 between 2009 and 2017.

These recalls were observed due to software design failure, component and material issues and packaging and labeling. Hence, such frequent product recall affects the company’s reputation and thus, the companies are offering a strong emphasis on the calibration of their products before and after commercialization.

This fact is considered as an important growth propeller of this demand by the medical device manufacturers market. In addition, rising demand for third party and in-house calibration services is another important driver for the need of calibration planning system such as Orcanos eQMS.

What could affect the implementation of Calibration system?

Some of the crucial factors include;

  • High Capital
  • The use of modular instrumentation
  • Regional and local companies dominating the market

 

Medical equipment calibration services are segmented in areas such as North America, Europe, Asia-Pacific and Rest of the World (RoW).

Presently, we see the European region is the largest market in the world, owing to extensive R&D practices by the industry, a large number of local and regional players and rapidly growing medical and healthcare infrastructure.

However, Asia-Pacific region is expected to be the fastest growing market during the forecast period 2019 – 2025. This growth is driven by rising demand for good quality services, steadily increasing medical infrastructure and rising government regulations.

The purpose of this article is to help identify both the current and future of calibration in the medical device market.

Orcanos provide for these players a greater potential by collaborating with the vendor directly over Orcanos eQMS cloud system to plan and execute the calibration program.

Some of the global service players include Fluke Biomedical, Tektronix, Inc., JPen Medical Ltd., NS Medical Systems and Biomed Technologies, Inc. amongst others. However, these companies have to face stiff competition from various players operating at the regional level and hence; collaboration or acquisition of cloud system is considered as an important strategy for the players to grow in this market.

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cGMP – Design and Development Outputs (SwRS-MecRS-HwRS-FwRS) – ISO 13485:2016 (8) Clause 7

June 16th, 2019 Posted by e-GMP, Requirements Management, Validation and Verification 0 thoughts on “cGMP – Design and Development Outputs (SwRS-MecRS-HwRS-FwRS) – ISO 13485:2016 (8) Clause 7”

In the same manner that we have design and development input. We also have design and development output. The result of satisfying the criteria for design input is the design output.  The output will possess risk assessment for the following ;

  • Assembly drawings
  • The specification for raw materials and components
  • Design and process
  • Instruction for installation and service
  • Guideline for the assembly process
  • Specification for labeling and packaging
  • Source code and technical files
  • Biocompatibility studies
  • Results of verification activity
  • Validation activities such as sterility, reliability testing or shelf-life studies and shipping.

 

The design and development output is also known as the first realized product. Depending on the type of product. It could be the first of several lines of assemblies or the first batch of products manufactured. The initial set of the first realized product must undergo evaluation checks. The checks will ensure that the design output requirement is met. Likewise, there will be serial number checks to ensure there is consistency in the process.

Orcanos ALM provides all the tools you need for complete coverage of the design outputs both from the product definition but as well from the change control as risk management according to ISO 14971:2012 with full traceability and impacts analysis tools, all in the same tool.

 

 

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