Medical Device Regulatory Assistance
and Expert Witness Services


Specializing in Electrical Medical Devices
Risk Management based on ISO 14971
Usability based on IEC 62366 and IEC 60601-1-6
Requirements for Access to the European Union

Expert Witness for Electrical Medical Devices



ABOUT US

We provide help with expert witness analysis, reports, and testimony for medical devices, and medical device conformity assessment, testing, risk management, and regulatory acceptance. Our mission is to provide this help as fast as possibe -- in order to help speed your product to the market where it can provide benefits to patients.

Fast information, straight answers, and clear guidance.
This is our promise to you when you invite us to
form an Active Alliance with you.

EXPERT WITNESS

Case summary from Stuart R. Day | Attorney at Law
Williams, Porter, Day, & Neville, P.C.
Phone 307.265.0700

Dale Hallerberg, P.E. with Active Alliance was retained by a medical device design/manufacturer/sales company named as a defendant in a Federal court action as an expert witness to assist in the defense of the medical device design/manufacturer/sales company. The plaintiff in that action alleged the medical devise design/manufacturer/sales company product caused a physical injury to him during operation.

Mr. Hallerberg conducted in-person testing of the product and came to the conclusion that the plaintiff’s allegation of how the devise performed during the alleged event was not possible. Hallerberg also participated in the preparation for deposing plaintiff’s expert witness. The Federal court ultimately entered summary judgment in favor of the medical device design/manufacturer/sales company finding its product was not defective.

Recommendation from Mr. Kevin B. Tucek, Co-Owner, Chief Engineer

Mr. Hallerberg labored diligently to ensure that any scenario plaintiff could present was addressed, tested and documented; in order to prepare an expert witness report with integrity. Our defending attorney stated that in his 20 plus years of practice, he had not seen a better more complete report. In our case, the judge concurred.

We would be willing to use Dale Hallerberg again for any service that called for expert knowledge of Electro-Mechanical devices, particularly medical devices and the ISO, UL, and FDA codes that regulate them, and believe Mr. Hallerberg would be an asset to other conpanies with the same needs.

PARTNERS

Medical Equipment Compliance Associates

Test experts for the IEC 60601-1 series
Testing and documenting compliance to medical
and laboratory equipment standards


MedicalRegs - Michael Wetherington

Class I and Class IIa/IIb medical devices
Webinars & Training, Clinical Documents, Pre-Compliance Design Review,
Coordination of Formal Certification with Agencies/Regulatory Bodies, and ISO 13485


(724) 218-0205

Support to medical device companies for U.S., Canadian, European,
and other international regulations.
Preparing FDA 510(k)s, IEC 60601-1 series of standards, Quality Systems,
CE Mark, Canadian Medical Device Regulations (CMDR), and training.

CONTACT US


USA phone 847-975-0563

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