MakroCare is an Expert Strategic Development and Commercialization Global Partner for Pharmaceutical, Biotechnology and Medical Device industries. Our Experience, Programs and Processes bring a New Dimension to Development Strategy, Regulatory/Risk Planning & Management, Clinical Research, Medical/Scientific Support and Emerging Region Expansion
Technical Analyst
• Support Devices and Diagnostics products of Global clients
• Involve in Risk Management (14971) full cycle, validation testing, Usability reports, and Technical Files support activities
• Support different activities of Post-Market Surveillance like complaint management and Vigilance aspects
• To support the Regulatory compliance - gap analysis and remediation of the technical files
• To understand and support for the QMS services as per ISO 13485/21 CFR part 820
• To understand classification of Medical devices as per Medical Device Rules 2017and assist in the identification of potential product technical file and/or clinical report improvements
• To understand EU classification of the product, CE Marking procedure and compilation and review of the MDR/MDD and IVDR/IVDD technical files for EU markets
• Follow Quality System procedures to ensure compliance with 21 CFR 820, ISO 13485, MDD/MDR, AIMD for regulatory compliance in alignment with client objectives
MakroCare | A MakroGroup Company | www.MakroCare.com
MakroCare is an Expert Strategic Development and Commercialization Global Partner for Pharmaceutical, Biotechnology and Medical Device industries. Our Experience, Programs and Processes bring a New Dimension to Development Strategy, Regulatory/Risk Planning & Management, Clinical Research, Medical/Scientific Support and Emerging Region Expansion.
MakroCare is Certified ISO 9001 (QMS), ISO 27001 (ISMS), ISO 20000 (ITSM), ISO 14155 (Medical Device Clinical Investigations)
MakroCare Awarded as:
• Best Biopharmaceutical Regulatory Consultancy Firm – Global Health & Pharma
• Best Pharmaceutical Strategic Development Specialist - UK Enterprises
• The Outstanding Consulting Firm - Insights Success
• AI Excellence in Regulatory & Automation Solutions - Acquisition International
• AI Excellence in Best Bio Pharma Development Partner - Acquisition International
• Best Practices Award - Clinical Informatics
• NJ Excellence Award - US Institute for Excellence in Commerce
• Best Biotech Award - US Commerce Association
• Clinical Research Team and Best Technological Development in Clinical Trials Finalists - Scrip Awards
• Circle Of Excellence – MerchantCircle
About MakroGroup | www.MakroGrp.com
Makro Group of Organizations established in 1996, Makro provides a complete range of solutions for every stage of business and information lifecycle.
• MakroCare, DDi, MakroTech and MakroScientific are MakroGroup Companies
• DDi Awarded by Insights Success, CIO, Corporate LiveWire, Pharma Tech Outlook, Clinical Informatics & SCRIP
• MakroTech is Awarded 3-time FAST 500 (Deloitte), 3-time INC 5000 company & TOP 100 diversity business in NJ
• MakroFoundation is a Suicide Prevention Helpdesk, part of Makro CSR Initiative, has counseled over 3000 people.