Medical Device Software Validation

 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. While the impact of COVID-19 on these deals is yet to be felt, it remains an advantageous avenue for organizations to pursue. But what are the common issues in healthcare mergers and acquisitions?   ·          Failed Cultural Integrations This type of issue has the potential of increasing operational costs. Staff are unsure about the correct working procedures or administrative processes, agreed upon by the integrated management but not accurately communicated business wide. This could result in mismanaged patients, poor re...

 Before introducing a new medical device onto the market, manufacturers should have a high degree of certainty that their manufacturing processes have the proper controls in place to produce products that are safe and meet specified user, technical, and regulatory requirements.  Process Validation for Medical Devices 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. IZiel provides complete expertise in process validation for Medical Devices and assists medical device manufacturers to consistently meet required parameters through their optimized manufacturing process. IZiel works with your team to assist you to complete all the following process validation activities ·          Process Validation Master Plan (PVMP) ·        ...

 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 c...

  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 specialised information. Configuration Management must include – 1.        Enterprise or Unified Supply Chain C...

 Process validation is a formal methodology that allows companies to manufacture products on approved and qualified equipment, with a defined process leading to products that consistently meet their predetermined specifications and quality requirements. Process Validation for medical devices 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. Pharma Vs. Medical Device Process Validations, Points to be considered as bellow. 1.        Qualification Strategy 2.        Timing of Critical Parameters 3.        Measurement Method 4.        Process 5.        Equipment 6.        Batch Production 7.        Process Va...