About
Casus Consulting offers regulatory affairs and authorized representative services specifically for the EU, UK, and Switzerland. They provide guidance on various medical device regulations, including the Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR). Key services include navigating post-market surveillance requirements, clinical evaluation plans, and market entry strategies for medical devices across different jurisdictions. Clients can benefit from comprehensive resources, including step-by-step guides for registering medical devices with the UK MHRA, understanding risk management concepts under ISO 14971, and preparing for audits. Their expertise is pivotal for manufacturers aiming to comply with varying regional regulations.
Related Vendors
MCRA is a global medical device, diagnostics and biologics CRO and consulting advisory firm offering regulatory, clinical research, quality assurance, reimbursement and compliance services. Since 2004 MCRA advises across clinical trial stages (site qualification to post commercialization) and provides FDA regulatory consulting and international regulatory affairs support. Its Compliance Services are designed to support healthcare organizations and medical device companies with corporate compliance programs. The firm also provides cybersecurity services for medical devices including risk assessments and advisory, and operates an AI & Imaging Center to support radiologic AI/ML studies aligned with regulatory expectations. MCRA additionally offers talent solutions and market access advisory for MedTech and life sciences clients.
Q&C Services delivers end-to-end quality and compliance consulting specifically for healthcare companies. With expertise in areas such as internal audits, pharmacovigilance strategies, and navigating Canadian regulations, Q&C assists businesses in obtaining necessary licenses and permits. Their Rapid Release Team™ expedites product entry into the Canadian marketplace. Offering extensive training solutions, both on-site and virtually, they are passionate about sharing knowledge in compliance and GMP. As Canada's largest independent full-service consultant, Q&C helps organizations successfully register and sell regulated products in alignment with Health Canada requirements.
Techmedics is an IT support and managed services company that offers managed IT services, managed support, cloud solutions and infrastructure for businesses. The firm presents a model with a dedicated IT team and a predictable monthly fee. Techmedics states it helps keep systems reliable and data protected, and supports businesses across multiple US cities including Los Angeles, Dallas, Denver, Phoenix and Las Vegas. The site positions the company as delivering scalable IT services for organizations of varied size and industry and references 25 years of industry experience. The record also references governance, risk and compliance (GRC) as an area of service interest.
