Razalution Bureau LLC
Contact: Salman Raza
Title: Principal Consultant
Specialty: Devices, IVD
Razalution Bureau is a brainchild of Salman Raza, a visionary and reformist at heart who has a passion for assisting companies and developing win-win partnerships. Through professional experience including working for renown EU NBs over the last two decade he has conquered medical device regulations, management systems, strategy and organizational culture awareness. As the founder and Principal Consultant of Razalution Bureau, Salman is assisting start-ups and helping mid-market growth firms realize their potential, by providing 360 degrees in services i.e. from vision, strategy, management system development, and regulatory strategy to effective team development through harmonized & productive work culture.
Razalution facilitate our clients to:
- Understand /fine tune their vision, and identify their ‘value proposition’
- Formulate their short- and long-term competitive strategy
- Develop their management system
- Formulate (medical devices) regulatory compliance strategy
- Conduct regulatory and quality management system audits in accordance with ISO 13485;2016, MDSAP:2017 and MDD 93/42/EEC & MDR 2017/745 etc.
- EU MDR 2017/745 Transition Training and Project Management
- Technical Documentation Preparation for CE Mark assessment (medical devices).
- Soft-skills development through personality and cultural awareness.
- International and Organization Culture Awareness through Hofstede Cultural Dimensions.
Years in Business: Over 15 years of experience in medical device regulations, including as Lead Auditor / Technical File Reviewer for European Notified Bodies [LRQA, SGS, LNE-GMED].
Work Phone: +1 832 704 8169
Email: [email protected]