Medical Devices

Overview

Veritas Quality Solutions provides comprehensive, end-to-end lifecycle solutions for medical device manufacturers across the full spectrum of device classifications. From initial classification and regulatory strategy through CE marking under EU MDR 2017/745, risk management, technical file creation, and post-market obligations, we support you at every stage of your device's regulatory journey.

Whether you are bringing a new device to market for the first time, transitioning an existing device from MDD to MDR, or expanding into new jurisdictions, our team delivers the expertise and hands-on support you need to achieve and maintain compliance.

Device Classifications We Support

Class I Medical Devices

Class I devices represent the lowest risk category under the EU MDR classification system. While Class I devices generally do not require Notified Body involvement for conformity assessment, they are not exempt from regulatory obligations.

Key Requirements for Class I Devices:

Self-declaration of conformity by the manufacturer

Technical documentation preparation and maintenance

EU Declaration of Conformity

UDI assignment and EUDAMED registration

Post-Market Surveillance (PMS) plan and reporting

Vigilance and incident reporting procedures

Important Note on Class Is and Class Ir:

Devices classified as Class Is (sterile) and Class Ir (reusable surgical instruments) require Notified Body involvement specifically for the aspects relating to sterility and reuse. The remaining aspects of conformity assessment may be self-certified. This hybrid approach requires careful planning to ensure all requirements are met.

Our Class I Services:

Classification confirmation and documentation

Technical file preparation

EU Declaration of Conformity drafting

UDI assignment and EUDAMED registration support

PMS plan development

Authorized Representative services (EC REP)

Notified Body coordination for Class Is and Class Ir aspects

Class IIa Medical Devices

Class IIa devices represent a moderate risk category and require full Notified Body conformity assessment under EU MDR. This includes devices such as certain surgical instruments, dental devices, and diagnostic equipment.

Key Requirements for Class IIa Devices:

Full conformity assessment by a Notified Body

Quality Management System certification (ISO 13485)

Comprehensive technical documentation

Clinical Evaluation Report (CER) with literature review

Risk management file (ISO 14971)

Post-Market Surveillance (PMS) plan

Periodic Safety Update Report (PSUR) — updated at least every two years

Post-Market Clinical Follow-Up (PMCF) plan

UDI assignment and EUDAMED registration

EU Declaration of Conformity

Authorized Representative (EC REP)

Our Class IIa Services:

Regulatory strategy and classification confirmation

Notified Body selection and liaison

Technical file preparation and review

Clinical Evaluation Report preparation

Risk management file development

QMS implementation and certification support

PMS plan and PSUR preparation

PMCF plan development

UDI and EUDAMED registration

Authorized Representative services

Class IIb Medical Devices

Class IIb devices represent a higher risk category, including devices such as certain implants, long-term surgical devices, and devices that administer or remove medicinal products. These devices are subject to the most rigorous conformity assessment requirements short of Class III.

Key Requirements for Class IIb Devices:

Full conformity assessment by a Notified Body

Quality Management System certification (ISO 13485)

Comprehensive technical documentation

Clinical Evaluation Report (CER) with systematic literature review

Risk management file (ISO 14971)

Post-Market Surveillance (PMS) plan

Periodic Safety Update Report (PSUR), updated at least annually for implantable devices, or as justified by risk assessment

Post-Market Clinical Follow-Up (PMCF) plan

UDI assignment and EUDAMED registration

EU Declaration of Conformity

Authorized Representative (EC REP)

Unannounced audit readiness

Our Class IIb Services:

Regulatory strategy and classification confirmation

Notified Body selection and liaison

Technical file preparation and review

Clinical Evaluation Report preparation

Systematic literature review with PRISMA methodology

Risk management file development

QMS implementation and certification support

PMS plan and PSUR preparation

PMCF plan development and integration

UDI and EUDAMED registration

Authorized Representative services

Unannounced audit preparation

Our Core Services

1. Classification and Regulatory Strategy

Accurate classification is the foundation of every successful regulatory submission. We analyze your device against the classification rules of EU MDR Annex VIII and other applicable frameworks, providing a defensible classification rationale that withstands Notified Body scrutiny.

What We Deliver:

Device classification analysis and confirmation

Regulatory pathway determination

Market prioritization and sequencing strategy

Customized regulatory roadmap with timelines and milestones

Gap assessment against applicable requirements

Risk identification and mitigation planning

Why It Matters:

Classification determines the level of regulatory scrutiny, the conformity assessment route, and the evidence required. An incorrect classification can result in delays, additional costs, or rejection of your submission.

2. CE Mark (MDR 2017/745)

The CE Mark is your passport to the European Union market. Under EU MDR 2017/745, obtaining and maintaining CE certification requires a comprehensive approach that addresses every aspect of the regulation.

Our CE Mark Services:

Technical Documentation Preparation

We prepare or review your technical documentation to ensure it satisfies the requirements of MDR Annexes II and III. This includes:

Device description and specification

Information supplied by the manufacturer (labeling, IFU)

Design and manufacturing information

General Safety and Performance Requirements (GSPR) checklist

Benefit-risk analysis and risk management

Product verification and validation

Clinical evaluation and PMCF

Notified Body Liaison

We manage communications with your chosen Notified Body, including:

Notified Body selection and application

Pre-submission meetings and clarification requests

Audit coordination and preparation

Response management to Notified Body questions

Declaration of Conformity

We prepare the EU Declaration of Conformity, ensuring it contains all required elements and is consistent with the technical documentation.

EUDAMED Registration

We support registration of your device and organization in EUDAMED, including UDI-DI assignment and data submission.

Our Track Record:

We are pioneers in Pakistan for MDR certifications, having successfully guided companies to Class IIa, IIb, and Is certifications with SGS Belgium. Our team was the first in the country to achieve these milestones.

3. Risk Management (ISO 14971)

Risk management is not a one-time activity but a continuous process that spans the entire product lifecycle. ISO 14971 provides the framework for identifying, assessing, controlling, and monitoring risks associated with medical devices.

Our Risk Management Services:

Risk Management Plan: Development of a plan defining scope, responsibilities, and methodology

Hazard Identification: Systematic identification of known and foreseeable hazards

Risk Estimation and Evaluation: Assessment of probability and severity of harm

Risk Control: Implementation of risk control measures following the hierarchy of inherent safety, protective measures, and information for safety

Residual Risk Evaluation: Assessment of residual risks against benefit-risk criteria

Risk Management Report: Documentation of the risk management process and conclusions

Production and Post-Production Monitoring: Integration of risk management with PMS and PMCF activities

Integration with the Lifecycle:

Risk management must be integrated with:

Design and development (ISO 13485 Clause 7.3)

Clinical evaluation

Post-market surveillance

CAPA and complaint handling

Supplier controls

We ensure that your risk management activities are not isolated but integrated throughout your quality management system.

4. Technical File Creation

The technical file is the comprehensive documentation that demonstrates your device's conformity with applicable requirements. It is the primary evidence reviewed by your Notified Body during conformity assessment.

Our Technical File Services:

Technical File Structure and Content

We develop technical files that satisfy MDR Annex II and Annex III requirements, including:

Documentation Gap Assessment

For manufacturers with existing documentation, we conduct a gap assessment against MDR requirements, identifying what is complete, what needs updating, and what needs to be created.

Technical File Maintenance

Technical files are not static documents. They must be updated throughout the device lifecycle to reflect changes, new data, and evolving requirements. We support ongoing maintenance and update activities.

5. PMS, PSUR, and Post-Market Clinical Follow-Up

Post-market activities are a critical component of MDR compliance. The regulation requires manufacturers to actively and systematically gather, record, and analyze data on the quality, performance, and safety of their devices throughout their lifecycle.

Post-Market Surveillance (PMS)

We develop PMS plans that define the methodology for collecting and analyzing post-market data, including:

Data sources (complaints, literature, registries, user feedback)

Data collection methods and frequency

Analysis and reporting procedures

Integration with risk management and clinical evaluation

Periodic Safety Update Report (PSUR)

Under MDR Article 86, manufacturers of Class IIa and IIb devices must prepare a PSUR as part of their post-market surveillance activities. The PSUR summarizes:

Results and conclusions of the PMS data analysis

Main findings and conclusions of the benefit-risk determination

Volume of devices sold and estimated population exposed

Main findings of PMCF activities

PSUR Update Frequency:

Post-Market Clinical Follow-Up (PMCF)

PMCF is a continuous process that updates the clinical evaluation and addresses specific clinical questions. We develop PMCF plans that:

Define objectives and methodology

Identify data sources and collection methods

Establish timelines and responsibilities

Integrate with the Clinical Evaluation Report

Address residual risks and clinical uncertainties

PMCF Methods:

Literature reviews

Patient registries

User surveys

Clinical investigations

Retrospective data analysis

Complaint and vigilance data analysis

Integration with CER

PMCF results must be integrated into the Clinical Evaluation Report, ensuring that clinical evaluation remains current and that conclusions on safety, performance, and benefit-risk remain valid.

The Complete Lifecycle

Our end-to-end approach covers every phase of your device's regulatory lifecycle:

Why Choose Veritas Quality Solutions

Proven MDR Expertise

We are pioneers in Pakistan for MDR certifications, having achieved the first Class IIa, IIb, and Is certifications with SGS Belgium. Our team has extensive experience across all device classes and regulatory pathways.

End-to-End Support

From initial classification through post-market surveillance, we support the entire lifecycle. You do not need to coordinate multiple consultants for different phases, we are with you throughout.

Global Network

We maintain relationships with Notified Bodies, authorized representatives, and regulatory experts around the world, giving you access to the resources you need for global market access.

Practical, Client-Focused Approach

We tailor every solution to your specific device, objectives, and constraints. Our work is accurate, defensible, and designed to withstand regulatory scrutiny.

Comprehensive Documentation

We prepare documentation that is complete, consistent, and compliant, reducing the risk of delays, questions, and nonconformities during Notified Body review.

Get Started

Whether you are developing a Class I, IIa, or IIb medical device, transitioning from MDD to MDR, or seeking to maintain compliance for an existing device, Veritas Quality Solutions is ready to help.

Veritas Quality Solutions, Your Partner in Quality Assurance