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EU MDR Compliance for Legacy Medical Devices: New Guidance
Legacy devices are products that were legally certified under older directives (MDD) but are allowed to remain in EU market. The EU MDR has released new guidelines for legacy devices. Legacy devices will have to mandatorily comply with these guidelines to...
Top 15 Medical Device Trends in 2026 To Watch
The top medical device trends in 2026 are being shaped by AI, robotics, sustainability, and patient-centered innovation. The medical device industry is focussing on improved, smart, connected, and accessible healthcare worldwide. Companies are focusing on agility,...
EU Authorized Representative: Roles & Responsibilities
An EU authorized representative is a legal entity in EU that non-EU manufacturers must appoint to act on their behalf. The authorised representative serves as the official contact point with EU authorities. It verifies that technical documentation and declarations of...
HVAC System in Pharma: Components, Importance & Common Problems
In this blog we have presented what is a HVAC system, its key components, and their roles. Additionally, we have presented the common problems HVACs face in pharma industry. What is a HVAC system? HVAC system stands for Heating, Ventilation, and Air Conditioning...
EU MDR Technical Documentation: Purpose and Contents
EU MDR technical documentation is the backbone of compliance for medical devices in Europe. It must comprehensively demonstrate conformity with EU medical device regulations and its documentation requirements. The MDR technical documentation must be prepared before...
EU MDR Rule 11 Classification for SaMD & CE Mark Process
In this blog, we have explained the EU MDR Rule 11 classification for SaMD. Additionally, we have detailed the CE mark certification process for SaMD. What is SaMD? Software as a Medical Device (SaMD) refers to standalone software that has a medical purpose on its...
5 Key Differences Between DCGI and CDSCO
The Central Drugs Standard Control Organization (CDSCO) is India’s national regulatory authority responsible for ensuring the safety, efficacy, and quality of drugs, medical devices, and cosmetics. It operates under the Ministry of Health & Family Welfare and...
CE Marking of Digital Health Technologies: EU MDR Guidelines
Digital health technology is the integration of digital tools into healthcare to improve prevention, diagnosis, monitoring, and treatment. CE marking of digital health technologies is mandatory under the EU Medical Device Regulation (MDR). It ensures that software,...
10 Best Practices for Internal Auditing of ISO 13485:2016 QMS
Internal auditing of ISO 13485:2016 QMS aims to verify compliance, identify nonconformities, and strengthen the medical device quality system. This structured process ensures audit readiness, regulatory alignment, and continuous improvement. Internal auditing of QMS...
CE Marking for Ophthalmic Medical Devices
Ophthalmic medical devices are specialized instruments and equipment used to diagnose, monitor, and treat eye conditions. These devices range from simple diagnostic tools to advanced therapeutic and surgical products. CE marking is critical for ophthalmic medical...
EU MDR Declaration of Conformity for Medical Devices: Insights
The EU MDR declaration of conformity (DoC) is a legally binding document required under EU medical device regulation (MDR). Every medical device manufacturer must issue the DoC before placing a device in the European market. It serves as the manufacturer’s formal...
4 Key Components of Effective ISO 13485 Resource Management
ISO 13485 resource management is a critical part of the Quality Management System (QMS) under ISO 13485:2016. ISO 13485 resource management ensures organizations maintain competent personnel, reliable infrastructure, controlled environments, and calibrated monitoring...
Quality Management System: 10 Benefits of an Effective QMS
A quality management system (QMS) is a structured framework designed to ensure consistent delivery of products and services that meet customer and regulatory requirements. It integrates elements, such as document control, training, audits, risk management, and...
MDSAP Remote and Hybrid Pilot Program: Key Insights
MDSAP remote and hybrid pilot program was launched to modernize medical device audits by introducing digital flexibility while preserving regulatory rigor. It emerged as a response to global challenges while ensuring manufacturers remain compliant across multiple...
Dubai to host the world’s largest healthcare event with record international exhibitors and visitors
With 33 international pavilions already confirmed, World Health Expo in Dubai and World Health Expo Labs in Dubai, the co-timed flagship events, are expected to welcome more than 270,000 professional visits from 180 countries and over 4,800 exhibitors China, Germany,...
Benefit-Risk Analysis for 510 (k) Clearance: 4 Key Elements
US FDA 510(k) clearance is a premarket notification pathway for medical devices intended for U.S. market entry. This pathway is essential for devices that are not exempt from FDA 510(K) and is not already legally marketed. Additionally, it is required for devices that...
HVAC System Validation in Pharmaceutical Industry: 4 Stages
In the pharmaceutical industry, the Heating, Ventilation, and Air Conditioning (HVAC) system is a critical infrastructure. It controls temperature, humidity, air quality, and cleanliness to ensure product safety, regulatory compliance, and worker comfort. HVAC systems...
CE Marking for Class I, II, and III Medical Devices: A Guide
CE marking is a mandatory requirement for medical devices sold in the EU/EEA. It demonstrates compliance with EU MDR safety, performance, and quality requirements. The process involves classification, conformity assessment, technical documentation, and post-market...
10 Key EU MDR Cybersecurity Requirements for Medical Devices
In the modern healthcare system, every connected device can be a potential entry point for hackers. Protecting these systems ensures that innovative digital medical devices remain safe, reliable, and trusted. Hence, cybersecurity is vital in the medical device...
10 Tips for Writing Effective SOPs for Medical Device Industry
SOPs are regulatory non‑negotiables. Regulators mandate SOPs to safeguard patient safety, reduce variability, and provide auditable evidence of quality control. In most regulated markets, SOPs are mandatory for licensing, certification, and market access. SOPs form...
3D Printing Intraocular Lenses: Your Complete Guide
Intraocular lenses (IOLs) are artificial lens used to replace the natural lens that has been removed during cataract surgery. Traditionally, these lenses are produced using cast molding and lathe-cutting methods. However, these approaches restrict design flexibility....
4 Consequences of Non-Compliance with ISO 13485 Guidelines
Medical device manufacturers should comply with ISO 13485 because it ensures patient safety, enables global market access, reduces regulatory risk. Non-compliance with ISO 13485 can have serious repercussions for medical device manufacturers. This can lead to...
Linking Design Qualification with ISO 14971 Risk Management
In the medical device industry, every design decision must align with safety and regulatory expectations. Design qualification (DQ) validates whether the chosen design, materials, and components meet user needs and regulatory requirements. ISO 14971 provides the...
Effectively Reviewing GMP Documents: A 10-Step Guide
Good manufacturing practice (GMP) documents are the backbone of pharmaceutical quality systems. It serves as controlled records that ensure consistency, traceability, and compliance with regulatory standards. We have prepared a comprehensive guide on how to review GMP...
5 EU MDR Medical Device Software (MDSW) Requirements
EU MDR defines medical device software (MDSW) as a software with medical purpose, whether standalone or embedded in a device. MDSW is regulated as an active medical device. Its classification is primarily determined by Rule 11 of Annex VII. Most diagnostic or...
Roles of Person Responsible for Regulatory Compliance (PRRC)
Person Responsible for Regulatory Compliance (PRRC) is a mandatory requirement under Article 15 of the EU Medical Device Regulation (MDR). It requires manufacturers and authorized representatives to appoint a qualified individual with expertise in regulatory affairs...
EU MDR Implant Card Requirements: Everything You Need to Know
An implant card (IC) is a patient-specific document that accompanies an implantable medical device. It provides essential information on the person's implanted medical device. It is required by Article 18 of the EU medical device regulations (MDR). Moreover, it must...
5-Step Guide to Obtaining Single Registration Number (SRN)
Single Registration Number (SRN) under the EU MDR is a unique identifier assigned to economic operators. The SRN is assigned once the economic operators are registered in the EUDAMED database. It serves as a critical regulatory tool for ensuring traceability,...
EU MDR General Safety and Performance Requirements (GSPRs)
General Safety and Performance Requirements (GSPRs) are a comprehensive set of criteria medical devices entering the EU market must meet. Outlined in EU MDR, they form the cornerstone of medical device regulatory compliance. GSPRs aim to ensure safety, performance,...
Class I Reusable Medical Devices: Class Ir under EU MDR
Class I reusable medical devices (Class Ir) refer to a subclass of Class I medical devices under the EU Medical Device Regulation. They cover reusable surgical instruments. Class Ir are non-invasive tools intended for repeated use in surgical procedures. They require...
EU MDR UDI Requirements: Everything You Need to Know
Under the EU Medical Device Regulation (MDR), the Unique Device Identification (UDI) system is mandatory for most medical devices. The aim is to enhance traceability, post-market surveillance, and patient safety. Manufacturers must assign a Basic UDI-DI for device...
Mandatory QMS for all Classes of Medical Devices per EU MDR
Quality management system (QMS) is a structured framework that ensures an organization consistently delivers products meeting customer and regulatory requirements. Notably, EU Medical Device Regulation (MDR) has specified mandatory QMS for all classes of medical...
10 Key Roles and Responsibilities of EU MDR Notified Body
An EU MDR notified body is an independent organization designated by an EU Member State. Notified Bodies play a central role in EU MDR compliance. They independently assess whether medium- and high-risk medical devices meet EU MDR requirements before they can be...
European Database on Medical Devices (EUDAMED): Objectives
European database on medical devices (EUDAMED) is the European Commission’s centralized IT system for medical device and IVD regulation. It has been designed to enhance transparency, traceability, and coordination across EU Member States. EUDAMED serves as the digital...
Introduction to EU Medical Device Regulation (MDR): Key Terms
European Union Medical Device Regulation (EU MDR) 2017/745 is a framework governing safety and performance of medical devices in EU. It came into full effect on May 26, 2021, replacing the previous Medical Device Directive (MDD). It aims to address gaps in oversight...
10-Step Guide to Hassle-free Integration of UDI into QMS
Integrating unique device identification (UDI) into your quality management system (QMS) will enhance traceability, compliance, and operational excellence. UDI will improve efficiency of the medical device supply chain as well as enhance patient safety and post-market...
8 Step Guide to FDA 510(k) Pathway for Unclassified Devices
The primary focus of FDA 510(k) pathway is Class I and Class II medical devices. However, medical devices that lack formal classification may still be eligible for 510(k) clearance. Unclassified devices can still follow the FDA 510(k) pathway, if a legally marketed...
CDSCO Mandates Risk Classification for Class A and B Medical Devices & IVDs
Recently, CDSCO has issued a notice reminding State Licensing Authorities (SLAs) that manufacturing licenses for Class A and B medical devices and IVDs must be issued only after verifying the device’s risk classification in the CDSCO’s official list. Notably, issuance...
Understanding the MDSAP Audit Cycle: A Comprehensive Guide
The Medical Device Single Audit Program (MDSAP) is one comprehensive audit for meeting the regulatory requirements of multiple participating countries. Achieving regulatory harmonization across different regulatory industries will help manufacturers easily launch...
IVD Technology Transfer in India: Key Components & Regulations
IVD technology transfer is crucial for manufacturers transitioning IVDs from development to full-scale production or relocating manufacturing between facilities. A successful transfer demands meticulous planning, comprehensive documentation, and alignment with...