PharmaLex MedTech Services – Global Medical Device and IVD RA/QA Consultants

PharmaLex MedTech Serbivices

PharmaLex MedTech Services Global – Regulatory, Quality, Reimbursement, Commercialisation Consultancy

As a global leader in medtech specialized services, PharmaLex has the knowledge and experience to guide you through those challenges across all global markets, including North America, Europe and Asia Pacific.

PharmaLex supports the entire continuum of regulatory, quality and market strategy needs for every therapeutic area. We have extensive experience in all product classifications for Medical Devices, IVDs, SaMD, Companion Diagnostics and Combination Products.

Whether your market ambitions are local or global, we are with you at every step of the journey

  • Strategic guidance
  • Product development and Program Management
  • Quality Management Systems set-up
  • Regulatory submissions
  • Post market compliance
  • Health economics.

Our commercial services include:

  • Due diligence
  • Supplier management

We partner with companies in every phase of development through to commercialization across the life sciences sectors, leveraging our experts’ market and medtech knowledge to help you achieve your goals.

From start-ups to top 10 multi-nationals, we partner with companies of every size across the medtech sectors, delivering robust, region-specific services for market success.

Featured Service Portal

  • European Union medical device regulation (EU MDR) and in vitro diagnostic regulation (IVDR).

PharmaLex is ready to partner with your business to market access and success.

Learn more at our site:

Contact us to learn more:

Luis Jimenez, MBA, RAC

VP of Business Development
p: +(951) 987 7281 m: +(424) 488 3457