MCRA's consultants are experts in achieving success with global regulatory bodies. Our team has industry leading experience with global regulatory strategy and deep understanding of the medical device lifecycle. We provide assistance through the developmental process, including conception and design considerations, pre-clinical and clinical testing, regulatory application through clearance/approval, and commercialization. Providing clients with the best-in-class representation to regulatory agencies by demonstrating the science, safety, and efficacy of their technologies.

Anesthesia and Critical Care Device Experience

MCRA's team has successfully navigated hundreds of global regulatory submissions. Our capabilities extend to European, Japanese, Australian, and Canadian markets, Successfully remediating Technical Files and Clinical Evaluation Reports (EU CER) for compliance with MEDDEV 2.7.1.Rev.4 for medical devices across the industry.

MCRA is a world-class provider of regulatory strategy and advice for Anesthesia and Critical Care devices, including:

  • Abnormal Breathing Sound Devices

  • Airway Monitoring Systems

  • Algesimeters

  • Anesthesia catheters, filters, and needles

  • Anesthesia gas and oxygen masks

  • Anesthesia gas machines and vaporizers

  • Anesthesia pain monitors

  • Apnea monitors

  • Breathing Frequency Monitor

  • Breathing Gases Mixer

  • Carbon dioxide absorber and anesthetic gas scavengers

  • CPAP and BiPAP devices

  • Cricothyrotomy devices

  • Dental Protectors

  • Depth of anesthesia monitors

  • Endotracheal, endobronchial, and tracheostomy tubes and stylets

  • End-tidal CO2 monitors and masks

  • Epidural catheters, needles, and delivery devices

  • Gas Analyzers

  • High flow oxygen delivery devices

  • Humidifier and masks

  • Hyperbaric chambers

  • Infant baby monitors

  • Laryngoscopes

  • Nebulizers

  • Nerve stimulators

  • Nitric oxide delivery and generating devices

  • Opioid use disorder devices

  • Oral and nasal airways

  • Oxygen concentrators

  • Oxygen conservers

  • Oxygen tents

  • Peripheral nerve blocks

  • Portable air compressor

  • Pulmonary function calculators

  • Pulse oximeters

  • Spirometers

  • Topical Anesthesia Applicator

  • Tracheobronchial suction catheters

  • Ultrasound guided nerve blocks

  • Ventilators

  • Ventilatory Effort Recorder

Global Regulatory Services

MCRA has industry leading specialization in the full spectrum of Anesthesia and Critical Care medical devices. Over the years, we have supported hundreds of clients seeking regulatory designations, clearances, and international registrations with Technical Files, Dossiers and CERs in global markets.

Our comprehensive regulatory services include:

  • Agency/Notified Body interaction

  • Clinical testing plan

  • Design dossier and technical file gap assessment

  • Device classification

  • Device listing

  • Due diligence services

  • Establishment registration

  • European Technical Files and Clinical Evaluation Reports (EU CER) compliant to the EU MDR

  • Gap Assessment of Key Chemical/Material Restrictions (such as those found in REACH, RoHS, BPR & CLP)

  • Global regulatory strategy

  • Import/export

  • Labeling

  • Medical device reporting

  • Mock audits

  • Notified body submission/response

  • Post-market surveillance

  • Pre-clinical testing plan

  • Quality system gap assessment

  • Regulatory file letters

  • Regulatory landscape assessment

  • Training (EU MDR)

Contact an anesthesia and critical care global regulatory Expert

Services in Anesthesia and Critical Care Devices

Anesthesia Quality Assurance

Anesthesia Reimbursement

Anesthesia US Regulatory

Anesthesia CRO