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The increasing adoption of positive airway pressure (PAP) devices, such as continuous positive airway pressure (CPAP) devices, is one of the major factors driving the growth of the sleep apnea devices market in Saudi Arabia. PAP therapy is considered the gold standard treatment for obstructive sleep apnea (OSA), which is the most common type of sleep apnea. PAP devices deliver pressurized air through a mask to keep the airway open during sleep, preventing breathing pauses and snoring.

The orthopedic biomaterials market has undergone a shift away from certain devices and towards new areas and medical devices.

The term medical devices cover a wide range of medical equipment from common tongue depressors to highly sophisticated surgical and advanced diagnostic equipment that are used in various specialized medical disciplines. These different types of equipment are extensively used in various sized hospitals ranging from rural health clinics to multi-specialty hospitals providing tertiary patient care. Similar to medicines and medical technologies, the medical devices are also highly essential for maintaining proper patient care.

Gastroesophageal Reflux Disease (GERD) is a chronic condition that is characterized by the regurgitation of stomach contents into the throat. GERD is also known as acid reflux disease and it occurs in people of all ages. In milder cases, GERD can be effectively treated with simple pharmacological therapies or by altering a patient's diet. In more severe cases, esophageal surgery might be necessary to remove the troublesome esophageal sphincter and/or improve a patient's general physical condition. GERD can develop when the lower esophageal valve relaxes or becomes weakened. The diagnosis of GERD and gastroesophageal reflux disease can be done by examining the medical history and symptoms. Although acid-reflux disease typically affects the upper body, some of its symptoms can extend down the esophageal tract, making GERD particularly troubling for people who sit or stand for long periods of time. This problem has given rise to a variety of different approaches to treatment, including invasive, surgical treatments, non-surgical treatments and more novel, non-invasive therapeutic approaches. The latest treatment option on the table involves using pharmaceuticals, such as selective serotonin reuptake inhibitors (SSRIs), to help reduce the effects of GERD. There are a number of advantages to this strategy. For starters, SSRIs are believed to have numerous side effects that tend to make them less attractive to certain groups of patients. Electrical stimulation (ESD) is another common form Gastroesophageal Reflux Disease (GERD) Treatment Devices. This technique involves the use of electrodes attached to the esophageal wall to generate a varying amount of electrical current. Antirheumatic drugs, which often cause symptoms similar to those of severe heart disease, are sometimes added to the mixture. A major disadvantage of using plicator devices with ESD is that the procedure can only be performed on an outpatient basis, requiring a patient to remain in the hospital for a fe

The factors such as rise inpreference for minimally invasive surgeries and increase inprevalence of peripheral & coronary heart diseases are expectedto boost the growth of the atherectomy device market in thecoming years. Furthermore, favorable medical reimbursement scenario from the government is anticipated to propel theatherectomy devicemarket growth. However, lack of skilled professionals and stringent regulatory scenario is expected to restrain the market growth.

Course "Validation and 21 CFR 11 Compliance of Computer Systems: Intermediate to Advanced" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion. Overview: Computer Systems Validation (CSV) also known as Software Validation is all-pervasive in the Life Sciences Industry. It is a requirement of all the predicate rules, as well as 21 CFR 11 and Annex 11. However, unless one knows how to implement CSV, it is often very hard to detect the requirement for CSV, and very hard to determine what needs to be done, to meet domestic and / or international regulations or business continuity requirements. In addition, the FDA has stepped up 21 CFR 11 inspections that include CSV. This course will build on the Validation and 21 CFR 11 Compliance Basic Course, to give hands on experience on executing on the computer systems validation of a system, and to discuss related activities such as Validation Master Plan, Infrastructure Qualification, Project Management for Validation and Validation of Test Tools The attendees must have attended the Basic Validation & 21 CFR 11 Compliance. This is a very hands-on class and the attendees will be expected to use templates provided in the class to create the complete package for the validation of a system The Seminar: This Hands-On course will provide the attendees with more detailed experience on validation / 21 CFR 11 compliance of a computer system, as well as details for activities associated with computer systems validation as follows: 1. Validation Master Plan 2. Complete Validation for a System 3. Excel Spreadsheet Validation 4. Change Control 5. SOPs 6. Test Tools Validation 7. Project Management for Validation Who Should Attend : * VP of IT * Director of IT * Quality Managers * Project Managers (for CSV / IT) * Validation Specialists * Database Administrators * System Administrators * Directors / Senior Directors of Discovery * Directors /

Course "Tougher Import Rules for FDA Imports in 2016" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion. Overview: FDA's and the Customs and Border Patrol Service (CBP) have become increasingly sophisticated and equally demanding in the submission of information and adherence to government procedures. Firm's that fail to understand and properly execute an import and export program find that their shipment is delayed, detained or refused. In 2016 entries must use the Automated Commercial Environment (ACE) entry filing system or face entry refusals and monetary penalties up to $10,000 per offense. A number of other factors can derail the expectation of a seamless import process. The course covers detailed information about the roles and responsibilities of the various parties with an import operation and how to correct the weakest link(s) in the commercial chain. The course will include tips on how to understand FDA's thinking and offer anecdotal examples of FDA's import program curiosities. Why should you attend: What happens when your product is detained? FDA will begin a legal process that can become an expensive business debacle. You must respond fully within short timeframes. This is not the time for you to be on a learning curve. You need to have a plan in place and know what you are doing. The FDA is steadily increasing the legal and prior notice information requirements. If you do not know what those requirements are and you initiate a shipment, your product is figuratively dead in the water. You must be accurate with the import coding information and understand the automated and human review process. If not, you can expect detained shipments. CBP is implemented a new "Automated Commercial Environment" computer program that changes import logistics and information reporting for FDA regulated products. Your shipment may be stopped before it is even loaded at the foreign port. What

Overview: This lesson is going to get back to the basics using multiple real life scenarios and "what if's". My goal is to make this very confusing and not well explained law easy to understand for the typical staff member. I will uncover myths versus reality as it relates to this enigmatic law based on over 1000 risk assessments performed as well as years of experience in dealing directly with the Office of Civil Rights HIPAA auditors. I will also point out multiple court cases I have been affiliated with where a staff member of a hospital or clinic has been sued or even imprisoned! I will also speak to real life audits conducted by the Federal government (I've been on both sides of these audits) what your highest risks are for being fined (some of the risk factors may surprise you). In addition this course will cover the highest risk factors for being sued for wrongful disclosures of PHI and the manner in which patients are now using state laws to sue for wrongful disclosures. Don't always believe what you read online about HIPAA, especially as it relates to encryption and IT, there are a lot of groups selling more than is necessarily required. Why should you Attend: Are you confused about HIPAA? Do you just want the basics and in plain English? Do you know there are civil and criminal penalties even for the rank and file staff member! Do you know what you can and can't do with protected health information? It is important to understand the new changes going on at Health and Human Services as it relates to enforcement of HIPAA for both covered entities and business associates as it relates to portable devices, texting, and emailing of PHI. You need to know how to avoid being low hanging fruit in terms of audit risk as well as being sued by individuals who have had their PHI wrongfully discloses due to bad IT practices. I have also been expert witness on multiple court cases where a business or medical practice is being sued for not doing their due diligence

Rationale for Clinical Trial Regulations Clinical trials, as we all know, are carried out to test the efficacy of a new drug or device being developed for a specific condition or disease. Clinical trials are experiments that have a high degree of risk if they are not properly implemented. For this reason, it is necessary for regulatory bodies to regulate clinical trials. The core rationale for regulating the various stages of clinical trials is that human subjects, who are part of the research, have to be protected. These clinical trial regulations are legislated at all stages: local, State, national and international. Clinical trial regulations are in force in different countries of the world. Common clinical trial regulations are also made globally by the International Conference on Harmonization (ICH), which has the mandate of setting out good practices for clinical trial regulations for trials done in global cooperation. These regulations cover the administrative, procedural and ethical aspects of clinical trials. Briefly, these are the areas in which there are clinical trial regulations for each of these aspects of clinical trials: Administrative: The administrative aspects of clinical trial regulations pertain to the way the clinical trials are run, and the way they are tracked and monitored throughout their lifecycle. A clinical trial is usually monitored by a sponsoring company or a Contract Research Organization (CRO), which the former hires at times for reasons of convenience and cost cutting. Clinical trial regulations in this area is obviously of importance because if something goes wrong at any administrative stage; these can be rectified. Procedural: Procedural aspects of clinical trial regulations relate to ways by which subjects are chosen for a clinical trial. Proper care has to be taken to ensure that the subjects are appropriate for the clinical study, are from the prescribed age, geographical, demographic, racial and gender-related cl

HIPAA Enforcement trends : Health Insurance Portability and Accountability Act (HIPAA) is a legislation of the American Congress. HIPAA enforcement consists of taking steps to confirm that rules set out in HIPAA are being complied with by the requisite entities. Primarily passed with the intention of ensuring that employees do not lose their health insurance benefits when they change or leave their current jobs; this 1996 law also has the protection and security of Protected Health Information (PHI) as one of its chief aims. The Office of Civil Rights (OCR), which enforces actions relating to HIPAA, imposes harsh penalties on healthcare organizations and Business Associates and Covered Entities that are proven to be in noncompliance of HIPAA requirements. What are HIPAA enforcement actions? The actions that the OCR takes to ensure implementation of HIPAA provisions constitute the essence of HIPAA enforcement actions. There are a good number of areas which the OCR can cite as constituting cases of HIPAA violations or noncompliance. A look at recent HIPAA enforcement actions point to a trend. These trends serve as an indicator of what to expect from HIPAA enforcement actions, which will help entities get some idea of what they should implement and what they should not and thus prevent being cited by the OCR. Security risk assessments are the foremost element of HIPAA enforcement actions: A look at recent trends suggests that HIPAA enforcement actions mainly target security risk assessments. This leads to harsh penalties, as happened in the case of New York-Presbyterian Hospital (NYP). The hefty $ 4.8 million penalty slapped in 2014 on this hospital was for data breach caused by insufficient security risk assessment. While this is the biggest sum fined; the OCR issued at least three other hospitals for putting in place inadequate security risk assessments in 2014. Risk management comes a close second: If inadequate security risk assessments come first in te

2-day In-person Seminar Applied Statistics, with Emphasis on Risk Management in R&D, QA/QC, and Manufacturing Overview: The 2-day seminar explains how to apply statistics to manage risk in R&D, QA/QC, and Manufacturing, with examples derived mainly from the medical device design/manufacturing industry. The flow of topics over the 2 days is as follows: ISO standards and FDA/MDD regulations regarding the use of statistics. Basic vocabulary and concepts. Statistical Process Control Statistical methods for Design Verification Statistical methods for Product/Process Qualification Metrology: the statistical analysis of measurement uncertainty, and how it is used to establish QC specifications How to craft "statistically valid conclusion statements" (e.g., for reports) Summary, from a risk management perspective Agenda Day One Lecture 1: Regulatory Requirements Lecture 2: Vocabulary and Concepts Lecture 3: Confidence Intervals (attribute and variables data) Lecture 4: Normality Tests and Normality Transformations Lecture 5: Statistical Process Control (with focus on XbarR charts) Lecture 6: Confidence/Reliability calculations for Proportions Lecture 7: Confidence/Reliability calculations for Normally distributed data (K-tables) Lecture 8: Process Capability Indices calculations(Cp, Cpk, Pp, Ppk) Day Two Lecture 1: Confidence/Reliability calculations using Reliability Plotting (e.g., for non-normal data and/or censored studies) Lecture 2: Confidence/Reliability calculations for MTTF and MTBF (this typically applies only to electronic equipment) Lecture 3: Statistical Significance: t-Tests and related "power" estimations Lecture 4: Statistical Significance: ANOVA calculations Lecture 5: Metrology (Gage R&R, Correlation, Linearity, Bias , and Uncertainty Budgets) Lecture 6: QC Sampling Plans (C=0 and Z1.4 attribute AQL plans, and alternatives to such plans) Lecture 7: Statistically valid statements for use in reports Lecture 8: Summary and Impleme

Course "Validation and 21 CFR 11 Compliance of Computer Systems: Intermediate to Advanced" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion. Overview: Computer Systems Validation (CSV) also known as Software Validation is all-pervasive in the Life Sciences Industry. It is a requirement of all the predicate rules, as well as 21 CFR 11 and Annex 11. However, unless one knows how to implement CSV, it is often very hard to detect the requirement for CSV, and very hard to determine what needs to be done, to meet domestic and / or international regulations or business continuity requirements. In addition, the FDA has stepped up 21 CFR 11 inspections that include CSV. This course will build on the Validation and 21 CFR 11 Compliance Basic Course, to give hands on experience on executing on the computer systems validation of a system, and to discuss related activities such as Validation Master Plan, Infrastructure Qualification, Project Management for Validation and Validation of Test Tools The attendees must have attended the Basic Validation & 21 CFR 11 Compliance. This is a very hands-on class and the attendees will be expected to use templates provided in the class to create the complete package for the validation of a system The Seminar: This Hands-On course will provide the attendees with more detailed experience on validation / 21 CFR 11 compliance of a computer system, as well as details for activities associated with computer systems validation as follows: 1. Validation Master Plan 2. Complete Validation for a System 3. Excel Spreadsheet Validation 4. Change Control 5. SOPs 6. Test Tools Validation 7. Project Management for Validation Who Should Attend: * VP of IT * Director of IT * Quality Managers * Project Managers (for CSV / IT) * Validation Specialists * Database Administrators * System Administrators * Directors / Senior Directors of Discovery * Directors / Senior

Tynor Exercising Ball Exercising ball is an excellent physiotherapy device to provide a pleasurable exercise plan for the hand, wrist, forearm and the fingers Safe and inert. High patient compliance. Excellent resilience for a long functional life . Compatible in thermal/hydrotherapy. Tynor Exercising Ball Features Ergonomic design and materials Two resistances available- Ortho (hard) & Neuro (soft) Compatible for thermal/hydrotherapy Flexible and pleasurable exercise schedules can be planned Better compliance Inert PU material, safe to use Excellent resilience, offers longer life. Tynor Exercising Ball Measurements Sizes Available: OR / NR

Clinical Research Organization for Healthcare provides clinical-study and clinical-trial support for drugs and medical devices, wherein many pharmaceuticals, biotechnology, and medical device industries having operations in the Europe Union states outsource research services to CRO to increase efficiency and improve productivity.

MedRhythms, a US-based digital therapeutics company, has launched its five-site randomised controlled trial (RCT) at rehabilitation hospitals and research centres to examine a post-stroke walking rehabilitation device.