| In today’s fast changing and increasingly complex
business environment, you need to be nimble and
efficient. That’s 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
isn’t 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 “as needed?consulting for ISO and GMP quality
assurance and regulatory affairs
- Quarterly audits of your ISO system or a supplier’s
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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