Medical Device Software Validation

  Manufacturers are expected to follow the quality system requirements described in FDA 21 CFR part 820This 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.  ...

Most medical device professionals and corporations are acquainted with the well-known pathways for market access in the United States - the510(k) or pre-market notification andpremarket approval (PMA). The 510(k) has options to choose from – traditional, special & abbreviated 510(k)s. The PMA also includes subtypes – traditional, modular, and streamlined. Medical device manufacturer have more options to bring their products to the market when compared to drugs or biologics. Some of the lesser known pathways available to medical device manufacturers include de novo , humanitarian device exemption (HDE), product development protocol (PDP), custom device exemption (CDE) and compassionate use. Manufacturers can choose either one pathway for their device or a combination of pathways based on the labelling of the device for which market clearance is needed. A well-traversed pathway can be used for bringing the device sooner to the market and later label expansion can be done to...

As a medical device company,you are expected to deliversafe, long lasting, which will make patient feel pleasant change in his life. For the progress of your company an innovation is must. While doing all these you must remember that you are governed by quality management system and regulatory compliance of your region.This task bears numerous responsibility - all that should be unbroken and documented inside your quality management system.  1. Is that the QMS is specifically made for medical device companies? Short answer is no but QMS is applicable in many manufacturing industries and service-oriented industry also.  QMS for medical device calls for special attention as it deals with human and negligence in this area can cost you heavily.  Many solutions are available with user friendly tools but there can be hidden cost involved in implementing the same which may not appear on the face price of that solution 2. Does the QMS software you are considering, align ...

3D printing process — that uses digital models to form physical devices out of materials like plastic and metallic powder. This is an excellent tool for medical device manufactures and it fabricates low-cost, custom-fit devices for patients as ordered by surgeon. The digital printing technology is new, but it is being used in many areas and specifically some parts with complicated design where usual die casting method may not work. It is used in automobile industry to fabricate some complicated part with precise accuracy. It is because of this property its use to fabricate some custom-made implant based on requirement of patient as judged by doctor based on CT scan etc. The 3 D printer is now having software which can read scan and print part accordingly which can become exact fit for the patient. Advantages - 1.       1.  PERSONLIZED MEDICAL DEVICES AND PATIENT-SPECIFIC IMPLANTS As suggested above 3 D printed implant is easy to prepare as most of the pre...

Medical devices are intended for use directly or indirectly on humans and hence risk associated with a medical device must be assessed. The presence of a large number of medical devices with varying uses makes it difficult to assess the regulatory requirements of each device. For this reason, various regulatory bodies have assigned different classes to medical devices based on the use, design complexity and risk posed when they are used. This classification of devices based on risk enables regulatory bodies to define different regulatory requirements & hence different review routes for bringing medical devices to the market. US FDA recognizes three classes – Class I, II & III for medical devices. This classification is based on the level of control necessary to assure safety & effectiveness. The classification procedures of US FDA are defined in 21 CFR 860. The European Union recognizes four classes – Class I, IIa, IIb and III. Class I includes Class I sterile,...

All the manufacturers supplying medical devices to the U.S. are required to maintain a quality management systemin compliance with the FDA 21 CFR Part 820.  This quality system regulation focuses on current good manufacturing processes and controls used for the design, manufacture, packaging, labelling, storage, installation, servicing for all the medical devices. 21 CFR Part 820 lays out the essential elements that a quality system shall embody, without describing specific ways to establish them, as the requirements must apply to a broad spectrum of medical devices . Thus, the manufacturer must develop a quality system that commensurate with the risk presented by their device, complexity of the device and manufacturing process, extent of the activities to be carried out and size and complexity of the manufacturer. The medical device manufacturers undergo USFDA inspections, to ensure compliance to 21 CFR Part 820, however, there is no certification method for Part 820 and so...

One of the important requirements of the medical device regulations is the documentation and maintenance of a systematic procedure to document performance and safety of medical devices once in the market. The requirements and the need for implementation of post-market surveillance system is outlined in various standards and regulations including EU MDR, MDD , MEDDEV, ISO 13485, ISO 14971 and US FDA among other guidelines. Post-market surveillance work has usually been dismissed by medical device makers. However, regulatory bodies globally areto implement additional rigorous needs for post-market surveillance workrequiring medical devicemanufacturers to take action to stay compliant.Regulatory bodies areencouraging manufacturers to take up proactive approaches instead of relying solely on reactive systems, like complaints observation. Post market surveillance as defined by EU regulations is to proactively collect and review experience gained from devices placed on the market. Thi...