A usable quality system creates consistency, speeds decisions, and keeps you inspection-ready. A bloated system stalls progress, and a thin one breaks under scrutiny. We build ISO 9001 or ISO 13485-aligned systems that are right-sized to your risk and scale and connect design controls, risk, clinical, production, and post-market activities to one traceable backbone.

→ QMS Implementation

Design control, risk, corrective and preventive action, and production all need to run on one backbone with clear ownership. If processes do not connect, traceability breaks in audits and submissions. We design processes, write procedures and templates, help select and migrate to electronic quality systems, train teams, and roll out the system across document control, design and risk, supplier quality, CAPA, post-market surveillance, and change control.

→ Audits

Audits and inspections reveal systemic risk and determine certification outcomes. Prepared teams move faster and close issues for good. We run internal and supplier audits, mock notified body and FDA inspections, and due diligence reviews. We also build corrective actions that address root causes and include effectiveness checks, so issues stay closed.

→ Change Management 

Uncontrolled change leads to field problems and findings. Controlled change allows speed without surprises. We implement risk-based engineering change and software release flows, including regulatory impact checks, connection verification, labeling, and training updates, to maintain clean traceability, ensuring approvals are faster and rework is reduced.

→ Post-Market Survelliance(PMS) & Vigilance

Post-market data is a regulatory obligation and a strategic input to risk and design decisions. Weak PMS systems lead to findings and reactive firefighting. We design and implement proportionate PMS and vigilance processes, define data sources and reporting routes, and connect outputs to risk management, clinical follow-up, and continuous improvement.

→ Supplier Management

Supplier Management Outsourced activities extend your quality system, whether you control them or not. Poor supplier oversight creates compliance and business risk. We establish supplier qualification, monitoring and quality agreement frameworks that are risk-based, scalable, and aligned with regulatory expectations across MedTech, BioTech and Pharma supply chains

→ GMP (Good Manufacturing Practice)

As products move from development into clinical and commercial manufacturing, gaps between quality systems and shop-floor practices become visible. Weak Good Manufacturing Practice (GMP) alignment leads to deviations, batch issues, inspection findings and supply interruptions. Regulators expect manufacturing to be controlled, traceable and consistently executed, even at low volumes or early scale. We support the design and implementation of GMP-aligned manufacturing processes integrated into your quality system. This includes process mapping, definition of controls and acceptance criteria, batch and device history records, deviation and nonconformance handling, and alignment of supplier and contract manufacturer activities. The result is a manufacturing setup that supports compliance, product quality and reliable scale-up without unnecessary bureaucracy.

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