ISO 13485 Design Control is considered the Bible for Medical Device industries. It comprehensively explains the ideal management system for designing and manufacturing medical devices, also known as MDQMS (Medical Devices Quality Management System).

Compliance with ISO 13485 enables any medical business to fulfill all the legal requirements of regulatory bodies. To be ISO 13485 certified, a business must have high competency levels to satisfy mandatory requirements.  The company will also meet end consumers’ expectations for high-quality medical devices by conforming to the standard.

ISO 13485 is also fully integrated with ISO 9001, making it simple to comply with US FDA and EU CE requirements, leading to a stronger brand image for the business as a whole.

Brief Intro of ISO 13485 Design Control MD-QMS

As mentioned earlier, ISO 13485 Design Control specifies the QMS for medical industries and fully demonstrates the ability to provide medical devices with excellent quality outcomes capable of satisfying consumers’ needs. It doesn’t matter if the medical device industry is related to any one of the operations like design and development, production, storage of the raw material or final product, distribution, erecting installation, or periodic services of a medical device in the form of remote technical assistance or regular visits to provide hands-on technical support.

Moreover, ISO 13485 can be used by suppliers and third parties that need a QMS specifically for medical device industries.

ISO 13485 Design Control in terms of ISO 13485

ISO 13485 Clause 8.3 provides a full package of guidelines allowing a business to conform to the standard when designing a medical product. The mandatory requirements of design and development in the light of ISO 13485 are:

  1. Documentation of Each Design and Development Phase

Each level of design and development must be recorded meticulously. This process allows the company to outline precisely how the product was developed as well as any trials conducted and the responsibilities of each team member per phase.

  1. Planning

Detailed planning of design and development can prevent unnecessary delays.  Initially, the business must identify goals and objectives regarding product design and development. The company should also break down the activities into milestones, with each window being documented and defined before the process continues.

The business should have the proper allocation of budget and resources to meet the needs of the project. It is essential not to forget the periodic review of the project of design and development so that if one department needs support to be provided on time, to avoid delaying the project deadline.

  1. ISO 13485 Design Control Inputs

The design input is the most crucial step, as the whole outcome is dependent on the quality of information. The design input should include:

  • Top requirements and reasons for developing the product
  • The demands or needs from the end-user
  • Physical features (tangible and intangible)
  • Feasibility of manufacturing
  • Safety factors and Ergonomic study
  • Risk control and Risk analysis
  • Servicing needs depending on the importance of the product
  • Costing feasibility

 

  1. Design Outputs

The outputs of design and development can be done in the following forms:

  • Inventory of raw materials, spare parts or sub-assemblies
  • Manufacturing process specifications
  • Environmental assessment and specifications
  • Identification, traceability, manufacturing, packaging, inspection, and distribution of the product
  • Submission of documents for regulatory authorities
  • History records of designs and trials if conducted on a pilot-scale or plant-scale and their outcomes
  • Product Validation
  1. Design Review

The finalization of the design isn’t the end. On the contrary, it’s just the beginning. It is essential to review the plan from time to time as the market is continuously evolving, and there is a constant need to make products better and better to stay ahead of the competition. Additionally, one must review the design to satisfy safety concerns if they get arise over time. In keeping with the standard’s requirements, design reviews should be documented extensively.

  1. Design Verification

Does the product live up to its purpose? The design should be verified so that the business knows that it works for what it was intended for.

  1. Product Transfer from R&D Scale to Plant Manufacturing Scale

Product transfer relies on moving the designed product over to the plant. It allows for scale production of the product. Additionally, R&D personnel from the lab can inform plant managers and operators about problems they should look for during the manufacturing process.

  1. Change Management of New Product

As with most standard, perfection is iterative. If there are production issues, the design may need to be revamped to deal with them. Changes that occur will also need to be fully documented to adhere to the standards.

Advantages of ISO 13485 Design Control Effective Process

In ISO 13485 Design Control, specific requirements are mentioned for new product design and the development process. Conforming to these guidelines makes new products more reliable and safer for the end consumer to use. However, periodic reviews will strengthen product attributes to the best level possible by minimizing design flaws and defects. Using reviews in this way results in higher quality products.

Design control guidelines in ISO 13485 play a significant role in the medical device industry, which is more sensitive to the end consumer. Patients in hospitals and clinics worldwide depend on the standard of medical devices to ensure that they have a safe stay in these institutions.

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founder of sync resource

About Author

Sunita Verma, Founder and President of Sync Resource started the company in 2009 with a vision to provide management consulting to small & medium size businesses around the country.
Sunita holds a Master’s Degree in Mechanical Engineering from Cleveland State University, Cleveland, Ohio, Bachelors in Mechanical Engineering(India) with prestigious gold medal by then President of India and renowned Scientist Dr. A.P.J. Abdul Kalam.
As an active philanthropist she believes in pay it forward and is a contributing member of charitable organizations like St. Jude’s Foundation and North Fulton Charities.


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