ISO 13485 for medical devices – Washington DC

ISO 13485 certification Washington DC

“Expert Certifier is a catalyst for business and process excellence, your business and process excellence is guaranteed through ISO certification with Expert Certifier in Washington DC “

Up your business, talk to our Expert Certifier masters who are available for you to coach and on how to get your business and process certified with ISO 13485, ISO 14001, ISO 45001,ISO 22000,ISO 27001,ISO 20000-1 and HACCP.


ISO 13485 certification in Washington DC is the International standard for Quality Management Systems (QMS). It provides your company with a group of principles that ensure a standard sense approach to the management of your business activities to consistently achieve customer satisfaction while standardizing your processes and continually improving effectiveness of the business processes.

By getting ISO 13485 Certified there’s the potential for increased business in both current and new markets. Additionally, there’s an overall improvement within the service/product quality being offered to the client. Having a certification in place will provide a definite advantage over other competitors and helps your ability in client acquisitions.

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What are the advantages of ISO 13485 certification to product owners?

  1. Sound and Complete Product Requirements.

What the standards require: Businesses are required to make process standards that outline the product’s requirements during a complete, unambiguous and appropriate manner, also as address the intended use of the device. Defining these requirements should include participation from the merchandise owner, also because the industrial design and engineering teams.

What this means: for every product, the team records all information that informs design and engineering decisions in a systematic way. These requirements capture quite just features; they include the device’s function, performance, and therefore the interfaces between component and software.

Problem avoided: It’s very expensive to find out a key feature of your device is missing once you’ve committed a design to a manufacture. By tracking and documenting each feature, performance, interface relationship and more, you’re forced to completely consider each aspect of your product.


  1. An outlined Process for Effective Risk Analysis.

What the standards require: Safety standards require you to define a strict process for risk management activities in product realization.

What this means: Risk management activities include the identification, assessment and prioritization of risks, followed by the potential hazards of using the medical device and are intended to stop harm to the user.


  1. A User-Centered Approach To development.

What the standards require: Standards require you to define a process for the application of usability in medical devices. This process is often incorporated into device design, development and risk management processes.

What this means: A user-centered approach to development ensures the merchandise is safe, effective and straightforward to use. Defining use scenarios, task flow, and intended users will help guide design decisions and ultimately, maximize user adoption. To spot possible risks early and sometimes, error analysis and use case studies are required to be conducted at each key development stage.

Problem avoided: Incorporating human factors into your device design early will save product owners from investing massive amounts of cash on the planning and build of a product that either doesn’t meet the user’s needs or could harm them during use (which also goes hand-in-hand with proper risk analysis).


  1. The merchandise Development Process Is subject To External Quality Reviews.

What the standards require: Recently released into the regulatory system, is the implementation of routine unannounced audits.

What this means: As an ISO-certified development partner, we are subject to routine visits from our standards company to watch the performance and compliance of our quality management system.

Problem avoided: This degree of accountability greatly reduces the danger and uncertainty assumed by the planning, engineering and manufacturing partners or groups.



We will do a FREE GAP analysis of your organization with reference to ISO 13485 Standard and provides you a quote.


Once you’ve got agreed to our quotation, our team will provide the specified trainings to you and can complete the documentation work required for ISO 13485 certification.


We will then conduct a pre assessment audit to make sure that you simply organization meets the specified certification requirements.


We will provide assistance during final certification audit to make sure that your organization achieves certification successfully.


We are a top quality conscious organization and believe Total Customer Satisfaction. So if you’re 100% satisfied and proud of our service.

Significance of ISO 13485 Standards:

The medical device industry is suffering from a posh array of regulatory systems, national and international standards and other requirements. We offer ISO 13485 certification in Washington DC which is globally recognized standard & helps a product in meeting compliance (national & worldwide). ISO 13485:2016 is the latest version of ISO 13485 standard which was published in July 2003. This standard is analogous to ISO 9001:2015 and is predicated on process model approach. Our certificate is formally recognized worldwide. Being a medical device manufacturer, it’s your responsibility to deliver a tool which is effective & safe for everybody. By implementing ISO 13485 standard in your organization you’ll achieve this goal.

How to proceed for ISO 13485 Certification?

  1. Identify the essential ISO 13485 standard requirements and the way they apply to your business.
  2. Establish quality goals and understand how they will best be incorporated into your business operations.
  3. Identify the standard management system’s parameters and develop and implement a totally documented plan.
  4. Contact us for certification.

How to get ISO 13485 certification in Washington DC – Consultants in Washington DC?

Our masters have more than 15 plus years of global experience, with hands-on experience in the field of ISO certification, assessment and training.

With Expert Certifier your Business and process excellence is guaranteed.

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