An expert with Alpha Devices gives an independent opinion in a defined scope, with an engineering team behind the work and a company in front of the client.

Your opinion is yours. Nobody at Alpha Devices or at the client decides what you find. We ask you to state what the evidence shows, what it does not show, and where the limits are. The same standard applies whichever side retained us.

The scope is written before you start. Every engagement has a written question, a budget, and a deadline. Work outside the scope is agreed first and added in writing.

We carry the client. Intake, conflict checks, engagement letters, retainers, invoicing and collection, scheduling, and the correspondence. You receive the technical question, the records, and the dates.

You have a laboratory and a second pair of eyes. Our test equipment, data extraction tools, document archive, and an engineer who checks the work before it leaves. You are not alone with a device and a deadline.

You are paid for your time. You set your hourly or daily rate. Alpha Devices invoices the client and pays you on a fixed schedule, whether or not the client has paid. Retainers are collected before work starts.

We look for people who have designed, built, maintained, used, or regulated medical devices for years, and who can explain what they know to someone who has not.

Fields

• Device design engineers: mechanical, electrical, systems, or software, with experience of design controls, verification and validation, and risk management under ISO 14971.
• Software and data engineers who have built or tested device software under IEC 62304, or who read device logs and data for a living.
• Clinical engineers and biomedical equipment technicians who maintain, service, and configure devices in hospitals.
• Clinicians: physicians, nurses, respiratory therapists, perfusionists, and others who use the devices every day and know how they fail in use.
• Regulatory and quality professionals with experience of complaint handling, MDR reporting, CAPA, field actions, 510(k) and PMA submissions, or quality system audits.
• Human factors and usability engineers who have run formative and summative evaluations.
• Specialists in alarms, materials, electronics, sterilization, or another field a device depends on.

Qualities

• Eight or more years in the field, or a depth of experience that stands in for them.
• Writes clearly and explains technical matters to people without a technical background.
• States what the evidence shows and what it does not, and holds that line under questioning.
• Keeps records: of time, of methods, of what was examined and when.
• Replies within two working days and can hold dates once they are set.
• Has testified, or is willing to be prepared for it. First-time experts are welcome; we prepare them.
• Has no current employment with a device manufacturer that is a party to the matters we take, and discloses every potential conflict.

We are not the right place for someone who wants to advocate for a side, who cannot commit time once a matter is accepted, or who cannot disclose their conflicts and testimony history in full.

• A current CV, with the devices and the roles named.
• Your testimony history: the matters in which you have given deposition or trial testimony, for the period the courts require.
• Your conflicts: employers, clients, and manufacturers you have worked for or hold an interest in.
• Your rates for review, testing, report writing, deposition, and trial, and the terms you need.
• Your availability, updated when it changes.

We keep these in your expert folder and ask you to confirm them every six months. They are shared with a client only when you have accepted a matter, and only the parts the matter needs.