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Medical Device Manufacturers require USFDA Approvals to sell their products in USA. USFDA differentiates product approvals in Class I, II &III depending upon the risk associated. The submissions include self-certification, 510(k) and PMA depending upon the class of the product.

The FDA medical devices have been classified into 3 classes.

Class I: They are low-risk devices.

Class II: They are medium-moderate risk devices.

Class III: They are of high risk, generally life supporting and life-sustaining.

Software Verification and Validation (Software V&V) is an integral part of software design that spans all the development stages as specified in IEC 62304 which addresses the Software Development Life Cycle (SDLC) of medical software and software embedded within medical devices. Software Verification is to test if the software was designed as per requirements and Software Validation is to test if the right product was built for the user. Medical device software validation generally occurs during or at the end of the development cycle. 

The difference between Software Validation & Software Verification can be answered by asking these mentioned questions:

·         Verification: Are we building the product, right?

·         Validation: Are we building the right product?

Software validation is a process of checking if the product will meet the customer’s actual needs, while verification involves procedures for making certain that the software is well-engineered, free of errors, and functional.

Following are the steps for Software Validation for Medical Devices

·         Create a software validation plan

·         Determine system requirements

·         Create a validation protocol and test specifications

·         Conduct and document tests

·         Establish procedures and write your final report

Process Validation IQ, OQ, and PQ is conducted to ensure consistent delivery of quality products meeting its predetermined specifications/requirements and quality characteristics. This enables to ensure the complete safety & efficacy of medical device.

IQ, OQ, and PQ process validation are sequential activities that manufacturers carry out to validate their manufacturing processes. IQ stands for Installation Qualification, OQ for Operational Qualification, and PQ for Performance Qualification. The purpose of process validation is to establish documented evidence that the production equipment is correctly installed, operates according to requirements, and performs safely. It is also to demonstrate that the manufacturing process under normal operating conditions will consistently produce conforming products.

IZiel works with your team to assist you to complete all the following process validation activities

·         Process Validation Master Plan (PVMP)

·         Process Characterization

·         Equipment Installation and Qualification (IQ)

·         Operational Qualification (OQ) –  

·         Performance Qualification (PQ)

Manufacturers are expected to follow the quality system requirements described in FDA 21 CFR part 820 This document guides to govern the design, manufacture, packaging, labelling, storage, installation, and servicing of medical devices intended for human use. The requirements in 21 CFR Part 820 are meant to ensure the safety and efficacy of medical devices sold in the US marketplace.

FDA conducts regular inspections of medical device manufacturers to ensure compliance with these regulations. The inspection process, known as the Quality System Inspection Technique (QSIT), evaluates a company’s internal quality processes to determine whether they are in alignment with or in violation of these regulatory requirements. If any violations are discovered, the inspecting agent from FDA will issue in the form of 483 Inspectional Observations, Warning Letters what is applicable

 Here are the most common mistakes companies run into with FDA 21 CFR Part 820:

1.  CAPA Procedures and 21 CFR Part 820.100(a) CAPA not followed adequately and repeat failure is detected

2.  Complaint Handling and CFR Part 820.198(a) Parameters described in procedure are not fulfilled and closure is not timely and adequate.

3. Nonconforming Product and CFR Part 820.90(a) Investigation is not proper, CAPA is not applied conclusion is not enough, preventive action is not proper, repeat failure is detected.

4.  Purchasing Controls and CFR Part 820.50 control for specification and artwork s not controlled purchase found with old label artwork and specification. PO does not mention specification or art- work reference

5.  Process Validation and CFR Part 820.75 System is not adequate, not followed, re-validation where defined is not done or done late, changes are not captured in validation. Protocols are not properly and timely approved before starting activities.

6.  Quality Audit and CFR Part 820.22 Audit done randomly, annual plan is not available, Audit closer is not proper, audit compliance are not reviewed in Management review meeting.

7.  Device History Records and CFR Part 820.184 Incomplete, completed in hurry just before audit, quality and regulatory are not in full control of DHR.

8.  Design Validation and CFR Part 820.30(g) Protocol is not adequate; all aspects of validation are not covered. Documentation is not proper.

9 PMS (post marketing surveillance) System is not followed. Some reportable incidents are not informed to FDA. Some critical or major complaints related to product not covered in PMS

10 UDI (Unique Device Identification) system documentation and records are poorly maintained.

11. Production, process control and quality control and assurance: System inadequate, documentation is not timely, and records are filled late or improper. Critical values are not verified by another independent person.

Mergers & Acquisition in the healthcare industry has been strong in recent years and is expected to grow. Acquiring a new company or product line can have a positive business impact, but it also comes with implementation, process, quality & regulatory challenges. Especially, in the medical device industry, failure to comply with regulations can result in the loss of authority to deliver products and services.

Because of this, it can be difficult for hospitals and healthcare organizations to know whether they should partner, when to partner and what type of organization to partner with.

There are a few things every organization needs to think about before they get started -

·         Before considering a partnership, first step back and evaluate your organization’s needs, goals, and long-term strategy.

·         After a thorough self-review, deciding what type of partnership to pursue should consider multiple factors.

·         Knowing when you’ve found the right match can be a complex process.

·         Understanding when to engage legal counsel is crucial.

IZiel enables the company to ensure compliance with the product specific standards & requirements by performing high-quality due diligence to mitigate risk and thereafter provide support to complete documentation as per USFDA / EUMDR requirements. IZiel has successfully worked with one of the world’s largest medical device manufacturers to update more than 2000 documents, 500+ approvals with release in Agile in a short span of 8-9 months.

Strong Project Management, Medical device Expertise, Quick Scalability of Skilled Resources are the key enablers of our success for Acquisition Integration Projects. As depicted above, IZiel’s approach has been very comprehensive and methodical.

IZiel team can support your team in various ways, including but not restricted to –

·         Post-Acquisition Assessment

·         Manufacturing Process Instructions

·         Process Optimization & Validation

·         Labelling

·         Software & Tool Validation

·         Documentation Support

·         Configuration Management

·         Component Remediation

·         Commercialization

Configuration management is “a process for establishing and maintaining the consistency of a product’s performance, functional and physical attributes with its requirements, design and operational information throughout its life.”

It is imperative to develop product configurations and manage effectively. A structured configuration management program ensures accurate and consistent product documentation (e.g., requirements, design, test, and acceptance documentation) along with the actual physical design of the product. Configuration Management plays an important role to ensure thorough product variations to enhance customer satisfaction, competitiveness, profitability & continuous changes / requirements. Therefore, it’s critical that the product and process configuration is unified across the organization, which minimizes handoffs of specialized information.

Configuration Management must include –

1.       Enterprise or Unified Supply Chain Configuration Solution

2.       Error-Proofing

3.       Intuitive and Flexible

The quality standards of medical devices consist of many aspects such as design control, risk management, vendor management etc. In this blog, we are going to discuss the importance of risk management for medical devices and steps to implement it during the product development stage.

Risk management is an integral part of the medical device product development lifecycle. It helps medical device developers ensure that the product is reliable, works as expected and causes no harm to the patients, operators, or the environment. In other words, the main purpose of the risk management cycle is to reduce or mitigate the chances of failure in the product.

Steps Involved for Risk Management

·         Risk Management Framework & Planning

·         Risk Analysis

·         Risk Evaluation

·         Risk Control

·         Reports and Documents

Until today, medical devices were complying with the MDD to sell their products in Europe. However major amendments are made in the current MDD to keep up with the growing technological advances in healthcare and medical devices. The new regulations passed by the Council of the European Union is Medical Device Regulations (MDR) 2017/745 that came into force in May 2017 & manufacturers have a transition time of three years until May 2021 to comply with the new regulations.

As companies plan and execute their transition projects to bring their organizations into compliance under the new Regulation, it's important to be aware of all the major changes that will require planning and action.

Medical device companies are required to comply with various new / updated regulations of MDR. Many Class I medical device companies are now required to comply along with various products are reclassified and all legacy products are required to receive approval too.