Ensuring Safety and Quality Every Step of the Way

At CRQA, we understand the critical importance of regulatory compliance and quality management in the medical device industry. Our team of highly qualified and experienced professionals is dedicated to helping your organization navigate the complex world of global regulations and standards, including ISO 13485.

CRQA ISO 13485 Medical Device Audit Expertise:

• Comprehensive audits: We conduct thorough audits of your quality management system (QMS) against the requirements of ISO 13485, identifying potential gaps and non-conformances.
• Experienced auditors: Our team consists of certified and industry-recognized auditors with extensive experience in the medical device industry.
• Global perspective: We have a deep understanding of global regulatory requirements for medical devices, covering major markets like Europe, US, Japan, Korea, India, China, and others.
• Tailored approach: We adapt our audit approach to your specific needs and product category, ensuring maximum relevance and effectiveness.

Beyond ISO 13485: Your Regulatory Compliance Partner

CRQA offers a complete suite of services to support your regulatory compliance journey. Our experience includes variety of regulatory consulting projects for European and US clients supporting regulatory and quality management business objectives and milestones at all product life-cycle phases within the new regulatory framework of the US-FDA QSR, 510(k) Premarket Notification, EU-MDR 2017/745 and EU-IVDR 2017/746:

• Regulatory Gap Assessment and Transition Planning
• Regulatory Strategy
• FDA Warning Letter Remediation
• Lean QMS support for Digital Medical Device App development
• eQMS Assessment, Selection, and Implementation
• QM Audits and Gap Assessments
• Technical Documentation
• Post-Market Surveillance

Regulatory gap analysis: Identifying areas where your current practices may not align with applicable regulations.

Regulatory submissions support: Assisting you with preparing and submitting regulatory documentation to various authorities.

Post-market surveillance: Helping you manage post-market activities and maintain compliance throughout the product lifecycle.

Training and workshops: Equipping your team with the knowledge and skills they need to understand and comply with regulatory requirements.

Regulatory Gap Analysis to prepare Clients for a pro-active plan for a timely transition into new European MDR regulatory Framework.

Clinical and Regulatory Strategy Development for Medical Device start-up companies to align business objectives with product development timelines and milestones achieving a successful market access.

Preparation and Representation of clients at regulatory advisory/strategy meetings with Notified Bodies and Government Agencies.

Developing educational training programs on European and US-FDA Regulatory Submission Pathway for clients and governmental agencies.

Developing Seminars and Training programs for Risk Management and Quality Management Systems.

Our Medical Device Auditors:

• Certified ISO 13485:2016 lead auditors
• Highly qualified: All our auditors hold relevant certifications and qualifications, including Certified Quality Auditor (CQA) and Lead Auditor (LA) credentials.
• Industry experience: They possess extensive knowledge and practical experience within the medical device sector, understanding the unique challenges and nuances of your industry.
• Communication and collaboration: Our auditors prioritize clear communication and collaboration throughout the audit process, ensuring a smooth and productive experience.

Technical Areas Covered

• Sterile/non-sterile single use medical devices
• Instruments Reusable surgical instruments
• Active/electro-mechanical medical device
• Non-active medical devices
• Medical software
• Active devices utilize software
• Devices design with chemicals/Pharmaceuticals Sterilization (ETO, Gama, radiation)

Partnering with CRQA:

Choosing CRQA as your partner means gaining access to a team of dedicated professionals who are passionate about helping you achieve and maintain regulatory compliance. We are committed to providing comprehensive, efficient, and cost-effective solutions that meet your specific needs.

Contact us today to discuss your medical device regulatory and audit requirements. We are confident that we can help you navigate the ever-changing regulatory landscape and ensure the safety, quality, and success of your medical devices.