Medical Device Quality Management Services

At D.med Technologies, we provide end-to-end medical device quality services designed to help you bring safe, compliant, and high-performing products to market—faster and with confidence. Our work goes beyond templates and audits: we integrate technical expertise, regulatory strategy, and industry insight into every project, helping manufacturers overcome complexity and streamline compliance.

From QMS implementation and ISO 13485 certification to audits, validation, and cybersecurity for connected devices, we deliver tailored, high-impact solutions for companies navigating today’s demanding regulatory environments.

Ensure ISO 13485 Compliance with Expert QMS Consulting

Achieving and maintaining ISO 13485 certification is critical for medical device companies operating globally. At D.med, we offer specialized QMS consulting services that help you build or optimize your system for maximum efficiency and full regulatory compliance.

Whether you’re preparing for FDA 21 CFR Part 820, MDR (EU) 2017/745, or international registrations, our team works alongside yours to design a custom QMS strategy that aligns with your product class, risk level, and commercialization goals. Through detailed assessments and strategic guidance, we help reduce delays, avoid rework, and position your company for long-term success.

Implementation of Quality Management Systems (QMS)

A robust QMS is more than a compliance checkbox—it’s the backbone of quality assurance, risk control, and operational excellence. D.med offers a structured, proven approach to QMS implementation, guiding clients from early planning to full execution across all departments.

Gap Analysis & QMS Strategy Development

Our first step is a comprehensive gap analysis that benchmarks your current processes against regulatory standards such as ISO 13485, GMP, and FDA QSR. We identify weaknesses, redundancies, and opportunities for improvement. Then, we design a strategic implementation roadmap that ensures every element of your QMS is both compliant and fit for your organizational needs.

This personalized strategy reduces friction, supports faster certification, and gives your team clarity on roles, timelines, and deliverables.

Documentation Setup: SOPs, WIs & Policies

We support the creation and organization of all core quality documentation including Standard Operating Procedures (SOPs), Work Instructions (WIs), quality manuals, and policies. Our documentation aligns with Good Manufacturing Practices (GMP) and meets the expectations of regulators and notified bodies worldwide.

This foundation not only ensures traceability and consistency, but also prepares your company for future audits, product updates, and process improvements.

Internal & Supplier Audits to Meet FDA and MDR Requirements

Auditing is an essential pillar of effective medical device quality management. Our expert-led internal and supplier audits are built to identify risks early, ensure readiness for inspections, and drive a culture of continuous improvement across your organization.

We conduct internal audits tailored to your processes, device class, and market targets. Our audits assess compliance with ISO 13485, FDA, MDR, and other applicable regulations, while offering clear, actionable insights on how to correct deficiencies and strengthen your system. We don’t just report findings—we provide strategic recommendations and support to help you close gaps efficiently.

Your device is only as compliant as your supply chain. We perform supplier qualification and surveillance audits to assess vendor capabilities, quality processes, and regulatory alignment. This is critical for companies relying on external manufacturing, testing, or component sourcing. Our evaluations help you manage supplier risks, reduce liability, and ensure your QMS extends effectively beyond your internal operations.

Facing a Notified Body assessment or FDA inspection? We deliver complete pre-audit support including mock inspections, document review, QMS walkthroughs, and staff coaching. This preparation increases your chances of a successful outcome and minimizes the risk of non-conformities, delays, or rejections. With D.med, you walk into audits prepared, confident, and in control.

Validation & Risk Management Throughout Product Development

Our services integrate validation and risk management from the earliest development stages through production and post-market activities. We help you meet global expectations while safeguarding patients and preserving product quality.

Product Validation & Verification

We design and execute V&V protocols that demonstrate your product performs safely and as intended. This includes design verification, software validation, and usability testing, all aligned with ISO 13485 and FDA requirements.

Our goal is to give you documented proof of performance—clear, defensible, and audit-ready.

Process Validation & GMP Alignment

Our team supports process validation in manufacturing and testing environments to ensure repeatability and reliability. We cover IQ/OQ/PQ, cleanroom protocols, and calibration, all within a GMP-compliant framework.

This ensures your processes consistently deliver safe, effective products—crucial for market access and patient trust.

Risk Management Files & ISO 14971

Compliant risk management is a cornerstone of quality. Using ISO 14971 as a foundation, we create and maintain full Risk Management Files (RMFs), including hazard identification, risk evaluation, control implementation, and residual risk analysis.

We help you document how safety is designed into your device—reducing regulatory friction and product liability.

Cybersecurity Solutions for Connected Medical Devices

As devices become more connected, cybersecurity has become a regulatory and market imperative. D.med offers specialized cybersecurity services tailored to Software as a Medical Device (SaMD) and other connected technologies, ensuring both technical security and compliance with regulations.

Compliance with ISO/IEC 81001-5-1

Our approach is based on ISO/IEC 81001-5-1, the latest global cybersecurity standard for health software. We help integrate its requirements throughout your lifecycle, from risk analysis and secure architecture to testing and maintenance.

This reduces exposure to threats and shows regulators you’re aligned with cutting-edge best practices.

Risk Assessment & Threat Mitigation

We perform detailed cyber risk assessments to identify potential vulnerabilities in software, hardware, data transmission, and cloud architecture. Based on findings, we design threat mitigation strategies tailored to your device and environment.

This process supports regulatory submissions while ensuring robust protection of patient data and device integrity.

Secure-by-Design Integration

Cybersecurity shouldn’t be retrofitted—it should be engineered from the start. We embed secure-by-design principles into your development process, creating a resilient foundation from ideation to post-market updates.

This future-proof approach supports long-term compliance, patient safety, and user trust.

Clinical Lifecycle Support: From Trials to Post-Market

Quality doesn’t stop at market launch—neither do we. At D.med Technologies, we offer integrated clinical lifecycle services that support your product from early feasibility to post-market surveillance. Our in-house clinical infrastructure and team of experts allow us to streamline your compliance, accelerate approvals, and protect your market position long term.

Clinical Trials & Feasibility Studies

We manage and support clinical trials for medical devices and In Vitro Diagnostics (IVDs), providing strategic and operational guidance across site selection, ethics submissions, trial management, and data analysis. Early-stage feasibility studies help validate your device concept, identify usability challenges, and ensure alignment with user needs and safety requirements—before significant resources are invested.

With our dedicated facilities and experienced clinical team, we enable faster, cleaner trials with more reliable outcomes.

Clinical Evaluation Reports (CER)

Creating a compliant and compelling Clinical Evaluation Report (CER) is vital under both MDR and FDA pathways. Our medical writers and regulatory consultants collect, analyze, and synthesize clinical data—both internal and published—into robust CERs that demonstrate safety and performance across your device lifecycle.

We ensure that your CERs are audit-ready, aligned with MEDDEV 2.7/1 Rev. 4, and tailored to your device’s risk classification and intended use.

Post-Market Clinical Follow-Up (PMCF)

After launch, PMCF activities become essential to maintain compliance and patient safety. We help design and implement PMCF plans, gather and interpret post-market data, and support updates to your CER, risk management files, and technical documentation.

Whether through registries, user feedback, or post-market studies, our team ensures you meet the evolving expectations of regulators while reinforcing your device’s real-world performance.

Why Choose D.med Technologies for Your QMS Needs?

Choosing the right partner for your medical device quality services can make or break your product timeline, compliance outcomes, and brand credibility.

Here’s why leading medtech companies trust D.med Technologies:

500+ successful projectsacross devices, IVDs, SaMDs, and combination products
Deep expertise in ISO 13485, MDR, FDA, and GMP
A unique blendof technical, clinical, and regulatory experience under one roof
Full in-house capabilitiesincluding software & hardware development, clinical operations, and cybersecurity
Global reachwith understanding of local market nuances

We don’t just offer services—we deliver strategic value, peace of mind, and real results.

Quality Services Across the Entire Product Lifecycle

Our quality framework spans the full lifecycle of your device, ensuring continuity, consistency, and compliance from concept to post-market monitoring.

Concept: Strategic QMS Planning

We help you set the stage with QMS planning that aligns regulatory requirements with business goals. Early-stage support includes target market analysis, regulatory pathway strategy, and risk classification assessments.

Planning: SOPs, Templates & Documentation

We provide ready-to-use and customized quality templates, SOPs, and documentation structures to ensure smooth execution and alignment with ISO 13485 and FDA QSR.

Design: Usability, Risk Files & Technical Docs

During the design phase, we assist with usability engineering, development of risk management files, and creation of technical documentation required for submission and audits.

Validation: Product & Process Validation

We conduct design verification & validation, process qualification, and ensure your device meets all safety and performance criteria. Our validation efforts are fully documented and inspection-ready.

Launch: Training, Labeling & Compliance

We support launch readiness with compliant labeling, staff training programs, and regulatory submissions to Notified Bodies and competent authorities.

Post-Market: Surveillance, Feedback & Changes

We ensure you remain compliant post-launch with surveillance programs, user feedback mechanisms, risk reassessment, and QMS updates in response to market data or regulatory changes.

Devices and Solutions We Specialize In

We offer medical device quality services tailored to a wide range of technologies and risk classes.

Class I-III Medical Devices

From low-risk devices to complex implantables, we understand the specific regulatory and quality challenges associated with each classification and provide bespoke solutions accordingly.

In Vitro Diagnostics (IVDs)

We support IVD manufacturers with IVDR compliance, clinical validation, risk documentation, and submission strategy.

Combination Products

Our multidisciplinary team navigates the overlapping worlds of device + drug regulation, offering services that align with both FDA combination guidelines and EU requirements.

Software as Medical Devices (SaMDs)

We specialize in SaMD compliance including software lifecycle validation, cybersecurity frameworks, and real-world data integration—ensuring your digital health innovations meet the highest standards.

How to Get Started with a Feasibility Study for Your Medical Device?

Healthcare & Hospital Systems

We help hospitals and integrated care networks ensure their medical technologies comply with quality and regulatory standards—especially when developing in-house devices or digital tools.

Biotech & Pharma

From combination products to diagnostics, we bridge the quality and regulatory gap between biologics and medical devices, helping you navigate dual pathways with confidence.

Medical Software & SaMDs

We guide software developers and digital health startups through the intricacies of SaMD validation, ISO 13485 adaptation, and real-world performance monitoring.

Public Health & Government

Our team supports public entities and contract manufacturers supplying devices to government programs, ensuring regulatory robustness and cost-effective compliance at scale.

Ready to Elevate Your Medical Device Quality?

Let’s turn your quality challenges into competitive advantages. Whether you’re launching a new medical device, upgrading your QMS, or entering new markets, D.med Technologies is your strategic partner for success.

Get in touch with our experts today to discover how we can streamline your path to compliance, speed up your time to market, and elevate your quality standards from day one.

Frequently Asked Questions (FAQs)

What is QA in medical devices?

Quality Assurance (QA) ensures that every medical device meets design, safety, and regulatory requirements through defined processes. It focuses on preventing defects by overseeing all stages—from development to post-market—under standards like ISO 13485 and FDA QSR.

What is a QMS for medical devices?

A Quality Management System (QMS) is a framework of procedures, policies, and controls that ensures compliance, product quality, and continuous improvement. For medical devices, it’s built around standards like ISO 13485, integrating elements such as risk management, design control, and CAPAs.

What is QC in medical devices?

Quality Control (QC) is the set of activities used to inspect and test medical devices during and after production. Its goal is to detect and correct issues before products reach the market, including final product testing and label verification.

What is QA vs QC?

QA is process-oriented and aims to prevent issues, while QC is product-focused and seeks to identify defects. Both are essential: QA builds a reliable system, and QC confirms the end product meets quality standards.

What is QMS and its purpose?

A QMS ensures medical device quality and compliance throughout the product lifecycle. It provides control, documentation, and risk management to meet regulatory requirements, improve processes, and ensure patient safety.