Medical Equipment

Lasers, Ionizers & Generators

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Medical Equipment

For your medical equipment project, you may find that design guidance, conformity assessment, and UL listing for medical equipment, is critical to your product and company success. If you are building a product that is patient handling equipment, medical diagnostic equipment, and or medical testing manufacturing equipment We support your new product design for medical equipment with standards reviews design reviews, and product safety support. When developing medical equipment, you will need to incorporate into your design the standards for medical equipment from UL, and for CE marking for medical equipment. We provide medical equipment standards interpretation and evaluation. As part of our conformity Discovery process, you will accelerate your product to market

Medical equipment must be certified and/or listed to a full range of UL standards, CE standards, and other risk-based standards. It is critical that electrical design of medical equipment, meet the requirements before testing and going to listing. The conforming design and equipment would then be sent to a third-party testing and evaluation laboratory. The design of medical equipment must be strictly to the standards and be thorough and complete. The details required for technical construction file for medical equipment due to the hazards and the risk to patients must be thorough and complete.

Contact us for engineering process design support, conformity testing third party testing and third-party evaluation for medical equipment to UL standards and CE requirements.

Product Approvals

Here are the different approvals we assist with pertaining to Medical Equipment.

  • UL ANSI IEC EN 60601
  • NFPA
  • CE

Process

You will need a way through the process to be certain your design is based on the standards that it will be tested to and needs to comply with in order to enter your desired market. Accelerate your product to market by utilizing our Conformity Discovery Process (c) for medical equipment.

Timeline

We can offer a basic timeline to get your product through the process and steps that you can take that will help to expedite the process. Each piece of equipment is different and we can quote your specific equipment.

Cost

$38-87K for most equipment. There are factors that you can anticipate will add to the cost and can be planned for in your budget.

Conformance

You will have a rapid way to evaluate and validate your product to using the required standards to get the necessary approvals for your markets. Here are a list of testing that may be required for products in the clean energy market.

  • EMC EMI Testing
  • Electrical Testing
  • Risk Assessment
  • Labeling
  • Manuals

Product Standards

These are the standards that may apply to your product in the clean energy field. We can help you to determine the best standard to meet your specific needs. And designing to the standard is going to be the best practice.

  • UL ANSI IEC 60601
  • UL ANSI IEC 61010
  • ISO - 11.040.01
  • ISO - 11.140
  • IEC 80601-2-x
  • IEC 62368-1
  • IEC 60601-1-8

Resources From The Field

CE Marking

Top Misses on UL, SEMI S2 and CE Marking

Today our CEO, Steve Barcik Amstel, is going to run through a presentation that he created and has shared with many of our clients about how to get your product certified. And more specifically how to include those things that others have missed and design those in now so that you have a product that

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NRTL UL Listing

From The Field #3 with High Tech Design Safety

Here at High Tech Design Safety we work with a variety of clients in multiple industries. And despite the differences, there are certain commonalities in the projects, one of which is that they must be certified or approved to meet required standards for that industry and use. Our CEO, Steve Barcik Amstel shares some of

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CE Marking

IEC UL ANSI 60601 Standard Overview Safety for Medical Equipment

Are you envisioning, planning, designing, building, or selling medical equipment? As a startup on through a fortune 100 company you will need to get to market fast, and win, using our proven “Conformity Discovery Process” © 2019 you will uncover conformity requirements early in process, and understand based on the standards what is required to

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