Medical Device Software Validation

 MDD (Medical device directive) which was regulation for medical devices then in some EU countries is now getting replaced with new regulation called MDR (Medical Device Regulation) MDR is designed to be an improved version and one of the important facts is that it influences and effective in all 27 member EU states including UK . Legal base of regulation will shift to EU and not like MDD where individual country was involved. One of the important steps is that even current companies with their products already in the market are also going to be influenced by new regulation and they must ensure their existing product comply to MDR. This will help overall improvement in the field of medical device. Making some empirical comparison; MDR is four times bigger document than MDD . The word safety appears 290 times as compared to 40 times in MDD. This itself explains the impact. Nothing is removed from MDD but lots of additions have been made in MDR. All additions are new to improve saf...

 Without going into definition of compliance as it is clear precise word but has lot of implications on your product and business. Compliance is not a choice, but it is must. It is not debatable. Though guidelines are available it becomes difficult to interpret sometime leading to wrong path. Taking compliance lightly may lead to product safety issues thus heavy price to business. In Medical device field like any other pharmaceutical, cosmetic product field, regulators has laid down certain rules and conditions for product safety and for the benefit of consumers who uses these products. Once you are compliant to say, US FDA requirement, it automatically means that products are safe to use, thus it gives sort of certification to consumers. Having said this, why it is necessary to have US FDA consultant ? Regulatory requirements are everchanging phenomenon and it is difficult to keep chasing the same and understanding the compliance need for each requirement. That is where these ...

  What is An FDA Form 483?   A Form 483 is a form through which FDA inspector reports and communicates the results of his audit findings to a head of facility. This is a regulatory form and all findings are bound to auditee and they need to be closed through corrective and preventive action.The observations are usually mentioned in descending order of importance. Some time they are referred with picture of spot or shown to a witness touring with auditor or document is attached to site some observation or noncompliance. Organisation needs to understand before auditor leaves. ·          Gain an understanding of observations noted and assure their accuracy ·          Understand the broader message the agency is sending ·          Identify and discuss any errors in observations ·          Ask questions · ...

  Risk is common word in human definition and even child learns the word risk from very age when he starts learning and start doing some adventure of childhood Everybody knows the word risk as common word vocabulary it has lot of importance in Medical device field. Though various documents are available, and experts have devised various methods to assess the same. Though we learnt risk based on our perception like we consider certain act as very risky and scared to do the same, stunt man who has practiced that act, does it so easily and risk in his or her perception for that act is very low. This type of perception cannot work in regulated world where we define risk based on assessment as defined in various well accepted standard documents. Let us understand this Medical devices, those have actually helped improve the standard of life for thousands and thousands of individuals. All those are associated with some sort of risk but are still released based on assessed risk. T...

  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...

  As a medical device company,you are expected to deliver safe, 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,...

 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.        PERSONLIZED MEDICAL DEVICES AND PATIENT-SPECIFIC IMPLANTS As suggested above 3 D printed implant is easy to prepare as most ...