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In todayís fast changing and increasingly complex business environment, you need to be nimble and efficient. Thatís why more and more companies are choosing to outsource their medical device regulatory affairs and quality assurance tasks as a way to ensure ISO compliance. In small and medium sized medical device companies, regulatory affairs and quality assurance tasks are often added to the responsibilities of senior management. As a result, regulatory compliance and ongoing quality assurance and improvement often does not receive the attention it requires. This can lead to potentially negative and costly consequences such as lost customers and non-compliant.

Medical device regulatory affairs and QA outsourcing isnít limited to smaller companies. Larger companies with established QA/RA departments often seek assistance with certain aspects of their quality and regulatory compliance activities to complement their in-house expertise, allowing them to overcome staffing shortages, provide training or obtain independent auditor assistance. Whatever your situation, Prinsip Mahir Sdn Bhd can help you maintain regulatory compliance, enhance your quality system, and most importantly, concentrate on core business objectives.

Our outsourcing services include: -

  • Full or ďas needed?consulting for ISO and GMP quality assurance and regulatory affairs
  • Quarterly audits of your ISO system or a supplierís quality system
  • Review of corrective actions and recommendations for resolution
  • Attendance at Executive Management Review meetings
  • Internal Auditor training for ISO systems
  • Complaint handling, contract review and surveillance audits
  • Document control and maintenance

Why you should choose outsourcing: -

  • Prinsip Mahir Sdn Bhd is a registered to NPC, Sirim, PSMB and Malaysia Medical Device Association
  • Prinsip Mahir is Technical Committee to SIRIM & DSM medical device standards development
  • ISO system is our business. We stay on top of the latest regulatory developments and are active in several government and industry associations
  • Outsourcing gives you the flexibility to respond to issues quickly, and concentrate on core business goals
  • Outsourcing tasks only when you need it saves money
  • You make continuous improvements to your quality management system to operate more efficiently
  • Our highly experienced staff consultants and Certified Lead Auditors specialize in ISO system
  • Our predictable, fixed pricing with no monthly retainers means no unexpected surprises

 

 

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