Medical Device Software Validation

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,...