Services

AlvaMed provides a multitude of client support including quality assurance, quality system development, regulatory, and clinical services to both large and small companies. Please select one of our services for specifics on what AlvaMed can do for you.

Device Registration & Approval

Device Registration & Approval

Need assistance with medical device registration and approval? AlvaMed can help you obtain medical device approval in all the major world markets. Our medical device registration experts in these markets have established relationships with their Health Authorities, and know how to complete your registration in order to obtain medical device approval as efficiently as possible.
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QMS Compliance

QMS Compliance & Auditing

AlvaMed is a Quality Management System (QMS) consulting and outsourcing company serving the medical device industry. We help you recognize when you first need a QMS, then our experts work closely with you to develop, install, and manage your QMS. AlvaMed has helped more than 50 clients install and manage their QMS including our participation to support the auditing of the QMS by FDA and Notified Bodies. AlvaMed is ISO 13485 certified – we practice what we preach. For larger companies we harmonize multiple quality systems into a single system, more resilient to external review and increasing intra-site communication.
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Regulatory Affairs Support<

Regulatory Affairs Support

As international Health Authorities’ medical device review processes become more complicated, partnering with an experienced regulatory advisory company can make a significant difference in your compliance efforts. Whether your goal is to develop the rationale for substantial equivalence of your medical device, confirm your regulatory pathway and reimbursement strategy, prepare for and obtain market approvals, a skilled regulatory consulting firm can assist you in your effort to meet all regulatory requirements.
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Clinical Affairs Support & Outsourcing

Clinical Affairs Support & Outsourcing

The success of a medical device clinical trial depends highly on the accuracy of the data collected. The AlvaMed clinical affairs team works in concert with you to ensure that your clinical trial data is collected, entered, cleaned and reported in accordance with the protocol and other requirements. The ultimate goal is to provide you with high quality, reliable data for analysis.
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