Fact Flyers related to Medtech
Fact Flyer
Our highly professional and experienced IVD & medical devices team, together with our expert biostatisticians, can support you from initial concept development through to formal design and product release.
Fact Flyer
We guide you from early strategic planning activities through product development, regulatory submission processes and post-approval / maintenance / post-launch activities. Our experts use technology-enabled solutions to support you through the entire product lifecycle. We deliver exceptional results — going above and beyond the standard to deliver tailor-made solutions worldwide.
Fact Flyer
PharmaLex brings a global reputation for excellence and trust built on decades of experience in quality, regulatory affairs and strategic consulting services. We are leaders in IVD global regulatory compliance.
Fact Flyer
The Medical Device Regulation (MDR – (EU) 2017/745) and In-Vitro Diagnostic Regulation (IVDR – (EU) 2017/746) present a significant challenge for medical device manufacturers. Our highly professional and experienced medical device team are available to provide support as required.
Fact Flyer
PharmaLex’s dedicated Medical Device team offers the breadth and depth of expertise to provide comprehensive support throughout the product lifecycle. We employ proven methodologies and hands-on support to optimize and customize quality and regulatory solutions which are delivered on time, in budget and with the highest quality.