ARC’s Research Quality division covers the full spectrum of Quality Management, Compliance, and Auditing.
We conduct QMS audits in accordance with vital regulations, including GCP (21 CFR Parts 812, 50, 54, and 56), ISO 20916, QSR (21 CFR Part 820), ISO 13485, and IEC 62304 for medical device software.
Additionally, we help vendors resolve audit findings and prepare for BiMO and other regulatory inspections.
Our experienced senior consultants from the medical device domain tailor QMS services to your project demands. From supplier auditing to remediation ahead of regulatory inspections, our expertise ensures compliance.
QMS Auditing: Ensuring Impeccable Standards and Readiness
Conducting rigorous QMS audits is paramount in the medical device domain.
In the absence of meticulous auditing, organisations risk non-compliance, regulatory challenges, and potential penalties. These issues can compromise trust, elongate product time-to-market, and even jeopardise operations.
Anticipating and addressing these audit nuances sets the stage for regulatory success.
We support you with:
Comprehensive preparation for BiMO, lab, and Dx sponsor inspections, including tailored mock BiMO audits.
Conducting rigorous supplier and vendor management audits, bolstered by risk-based audit schedules, ensuring streamlined operations and unwavering quality.
Overseeing the integrity of Documentation/TMFs and conducting detailed audits of clinical/investigational sites, as well as "For-Cause" situations.
Ensuring swift NC remediation and effective CAPA management, addressing discrepancies with precision.
Providing comprehensive audit services to uphold industry regulations and standards.
Quality Management: Upholding Excellence Across Operations
In the medical device landscape, ensuring quality is not just mandatory—it’s integral for business excellence.
Quality management deficiencies can lead to operational hiccups, regulatory setbacks, and unfavourable market reception. Proactive quality interventions can pre-empt these challenges.
With our dedicated quality management suite, your operations are guided, supported, and enhanced at every stage, ensuring nothing is left to chance.
Rely on us for:
Detailed GCP assessments paired with the meticulous development or refinement of GCP quality systems.
Robust SOP development, onsite and remote quality support, and tailored design control support, ensuring all processes meet industry benchmarks.
Swift remediation work, NC and CAPA closure, ensuring your operations remain within regulatory boundaries.
Guiding the IVDR transition in terms of processes and systems, and ensuring adherence to ISO 13485 and 21CFR Part 820 standards.
From SOP development to GCP assessments, we drive quality at every step.
Compliance: Aligning Operations with Regulatory Demands
Compliance in the medical device industry is critical. Achieving and maintaining it requires expertise and a structured approach. Missteps can result in delays, added costs, and reputational damage. ARC ensures your operations remain compliant, mitigating risks and enhancing operational efficiency.
With our structured approach, you benefit from:
Assistance with the In Vitro Diagnostic Directive (98/79/EC) and its transition to IVDR (2017/746).
Ensuring operations align with Good Clinical Practice (GCP), ISO 20916 (IVDs), ISO 13485 (Medical Devices), and ISO 14155 (GCP for Medical Devices).
Navigating the complexities of CE Marking and the EU Directive for product safety.
Implementing and managing a Quality Management System (QMS) that adheres to ISO 13485 US 21 CFR 820 Quality System (QS) Regulations and ISO14971 Medical Device Risk Management.
Keeping projects on track with a systematic approach to regulatory adherence
Risk Management: Ensuring Product Safety and Compliance
Effective risk management is the foundation of product longevity and safety in the medical device sector.
Overlooking risk can lead to product failures, increased liabilities, and harm to brand reputation. A forward-looking risk strategy ensures product success and longevity.
Our in-depth understanding of risk management positions your products for market success, ensuring they are safe, compliant, and optimised for user needs.
Engage ARC for:
Comprehensive coverage from device classification to post-market surveillance.
Adherence to the most recent ISO standards to identify and mitigate 'use errors'.
Integration with current international standards for assured compliance and safety.
Implementation of Risk Management and Usability Engineering principles throughout a product’s lifecycle.
Navigating global regulations with a risk-centric approach
