| MCRA

Mock Trial: Outsourcing to Prepare for Your Class III Premarket Panel

For a company navigating a Class III medical device’s path to market, the U.S. Food and Drug Administration (FDA) panel presentation is the make-or-break point.

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Mock Trial: Outsourcing to Prepare for Your Class III Premarket Panel

For a company navigating a Class III medical device’s path to market, the U.S. Food and Drug Administration (FDA) panel presentation is the make-or-break point.

Read more about Mock Trial: Outsourcing to Prepare for Your Class III Premarket Panel

MCRA Expands, Moves to New DC Location

Musculoskeletal Clinical Regulatory Advisers, LLC (MCRA), a leading advisory firm and Clinical Research Organization (CRO) to the neuro-musculoskeletal and orthopedic industry, is pleased to announce that it has moved its headquarters in Washington, DC.

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SANUWAVE Health Submits de novo Petition for FDA Review and Classification of the dermaPACE System to Treat Diabetic Foot Ulcers

SANUWAVE Health, Inc. (OTCBB:SNWV) today announced that it has submitted to the U.S. Food and Drug Administration (FDA) a de novo petition requesting Agency review and classification of the dermaPACE System for treating Diabetic Foot Ulcers (DFU) as a Class II device.

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Four Questions to Help You Avoid Losing a CE Mark

A Clinical Evaluation Report (CER) is part of the process through which a medical device is certified or recertified to carry the CE mark; it applies to all device classifications.

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MCRA Assists Cartiva, Inc. with Obtaining FDA PMA Approval for the Company's Synthetic Cartilage Implant (SCI)

Musculoskeletal Clinical Regulatory Advisers, LLC (MCRA) announced today its role in the successful Premarket Approval (PMA) application decision by the U.S. Food and Drug Administration (FDA) to approve Cartiva, Inc.'s Synthetic Cartilage Implant (SCI) for the treatment of osteoarthritis in the first metatarsophalangeal (MTP) joint (the "great" or "big" toe).

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MCRA Assists VertiFlex, Inc. with Obtaining FDA PMA Approval for the Superion® Interspinous Spacer System

Musculoskeletal Clinical Regulatory Advisers, LLC (MCRA) announced today its role in the successful approvable decision by the U.S. Food and Drug Administration (FDA) for Wright Medical Group, Inc.'s (NASDAQ: WMGI) Augment® Bone Graft Premarket Approval Application (PMA)

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MCRA Hires Experienced Trauma And Total Joint Expert To Expand Its Leading Orthopedic Regulatory Team

Musculoskeletal Clinical Regulatory Advisers, LLC (MCRA), a leading medical device consulting firm and clinical research organization to the medical device industry that integrates five business value creators regulatory, reimbursement, clinical research, compliance and quality assurance, has hired David McGurl, former Food and Drug Administration (FDA) Premarket Senior Lead Reviewer, to join its regulatory team as a Director.

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MCRA Assists Wright Medical Group, Inc. with Obtaining FDA PMA Approvable Decision for Augment® Bone Graft

Read more about MCRA Assists Wright Medical Group, Inc. with Obtaining FDA PMA Approvable Decision for Augment® Bone Graft

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