Consulting

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Description of Service

We have helped hundreds of clients with all aspects of safety compliance and strive to be your go to expert for issues that may arise. We have expertise in all aspects of 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. 

Consulting services can either be short term including questions or design reviews or longer term commitments like 1 or more days per week for ongoing help during a project.

Short term consulting

Whether it is a design review meeting or a question that came up during an audit we consider this short term consulting. All our consulting will be followed by notes of major points discussed in either formal letter or email. We have experience in the following topics.
  • Review process standards needed for IEC 60601 compliance like:
  • Usability process, IEC 60601-1-6 and IEC 62366,
  • Risk management process, ISO 14971, and
  • Software process, Clause 14 and IEC 62304
  • Prepare insulation diagram for product
  • Define Essential Performance

Long term consulting

Need to hire a safety engineer for a project? Consider us instead for 1 or more days a week to help with your short term medical device compliance needs rather than adding a new employee to your firm. A one time design review is great at finding large problems but can often not be enough to uncover all the issues that may cause problems in the end. Having an OBCM engineer onsite for one or more days a week allows your engineers to ask compliance questions when they arise it also allows us to participate in your meetings to ensure designs are in compliance from the very beginning to the very end, saving time and money. We have a wide range of expertise in verifying medical products. We can also help create and maintain documentation needed for compliance including risk management records and design documentation. This service has been beneficial for many medical device companies and test labs. Our only goal is to make compliance easy and efficient for our customers.

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Billing Rate

Our Consulting rate is 180 USD/h, 1,440 USD/day with a project minimum of 6 h, 1080 USD. We find questions typically take 1 to 6 hours to answer. We typically provide a quote for 25 hours to be billed as time is accrued

We also offer longer term consulting at a lower rate of 150 USD/h, 1,200 USD/day with a minimum of >5 days or more per month, for 2 or more consecutive months. For projects that last longer than 2 months, time can be added on an as needed basis.

Travel and Living Fees

Typically in the early stages of a project we may see the need for an on-site meeting, so familiarity of product, staff, and computer records can be gained. Later more work can be done off-site, at our office and follow up meetings can be done with tele/video conferencing. 

For Consulting services, if you are local to the Boston area you can visit our office or we may need to travel to your site. Travel and living costs incurred for on-site meetings are included in our quote. We estimate max travel cost and bill for actual travel costs with receipts and mileage. For travel over 1 hour from our office, our quote includes a charge for 1/2 * ( travel time less 2 h ). For flights, travel time = flight time + 2 hours, each way. 

For On-site consulting services, travel and living costs incurred are included in our quote. We estimate max travel cost and bill for actual travel costs with receipts and mileage. For travel over 1 hour from our office, our quote includes a charge for 1/2 * ( travel time less 2 h ). For flights, travel time = flight time + 2 hours, each way.

Service Agreement

We ask all new customers to sign a Service Agreement. This link allows you to review and e-sign our Service Agreement and forward on to Frank O'Brien for final e-signature. All parties automatically get emailed a copy. We are also happy to sign any Consulting or Contractor Agreement you may have based on a mutual agreement.