978-697-4665
Accreditation by A2LA to ISO 17025:2017

Consulting

Consulting

We can help with all aspects of safety compliance and be your go to expert for issues that may arise.

We have expertise in the IEC 60601 family of standards and related process standards such as Usability process, IEC 60601-1-6 and IEC 62366, Risk management process, ISO 14971, and Software process, Clause 14 and IEC 62304.

We have experience in the following topics:
  • Review process standards needed for IEC 60601 compliance
  • Usability process, IEC 60601-1-6 and IEC 62366
  • Risk management process, ISO 14971
  • Software process, Clause 14 and IEC 62304
  • Prepare insulation diagram for product
  • Define Essential Performance

Consulting services include:

  • Design reviews
  • Question(s) that came up during an audit
  • On-site safety engineer for a project
Consider us to help with your short-term medical device compliance needs.

Our Services

Field Evaluations
Consulting
The EU Machinery & Low Voltage Directives
IEC 60601-1
IEC 61010-1 Testing
Semi S2
EMC Partnership Testing
510K Submission, MDR and Regulatory Guidance
978-697-4665
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Device Conformity and Testing LLC acquires the test equipment, standards catalog, and customer information of O’Brien Compliance Management.

I’ve worked with Gregg over the years and know him to be one of the finest compliance engineers. I’m thrilled to see Gregg carry the safety mission forward. I’ve told him I’m available to help smooth any transition issues for those customer choosing to continue working with Device Conformity and Testing." — Frank O'Brien