Medical Device

Medical Device and IVD Solutions: Expertise That Matters

 At PharmaRelations, we specialize in quality management and regulatory compliance for medical devices and in vitro diagnostics (IVDs). With a deep understanding of industry standards, including ISO 13485, ISO 14971, MDR, and IVDR, we help businesses successfully navigate complex regulatory landscapes. Our expertise spans from start-ups, where versatility and innovation are critical, to large corporations requiring in-depth, specialized knowledge. Our experience covers diverse fields such as dentistry, ventilation systems, x-ray technology, medical device software, and combination products. Whether you're introducing a groundbreaking solution or ensuring compliance for existing products, we offer the knowledge and support you need to thrive in the medical device and IVD industries.

Our Services: Compliance solutions

Audits

• Conducting internal audits to ensure compliance with ISO 13485 and MDR/IVDR. 
• Performing supplier audits for supply chain quality assurance. 
• Supporting third-party audits and inspections. 

Risk and Post-Market Management 

• Comprehensive risk assessments in line with ISO 14971. 
• Managing post-market surveillance, vigilance reporting, and CAPA processes. 
• Overseeing lifecycle management, including handling change control, complaints, and deviations. 

Training and Mentoring 

• Delivering customized training programs on MDR, IVDR, and ISO 13485.
• Hosting workshops and providing mentoring to build internal expertise. 

Notified Body and Competent Authority Support 

• Assisting with notified body sourcing and submission processes.
• Supporting communications with Competent Authorities.