ISO 13485 Certification Services in the US

ISO 13485 is an ISO standard, published in 2003, that represents the requirements for a comprehensive management system for the design and manufacture of medical devices. This standard supersedes earlier documents such as ISO 46001 and ISO 46002 (both 1997), the ISO 13485 published in 1996 and ISO 13488 (also 1996).

While it remains a stand-alone document, ISO 13485 is generally synchronized with ISO 9001. A fundamental distinction, however, is that ISO 9001 requires the organization to demonstrate continuous improvement, whereas ISO 13485 requires only that they demonstrate the quality system is implemented and maintained. Other specific differences include:

• The promotion and awareness of regulatory requirements as a management responsibility, will be providing resources and during reviews. An example of the market specific regulatory requirements is 21 CFR 820 Quality System Regulation for Medical Devices sold in the United States.
• Controls in the work environment to ensure product safety
• Focus on risk management activities and design transfer activities during product development
• Specific requirements for inspection and traceability for implantable devices

Compliance with ISO 13485 is often seen as the first steps in achieving compliance with European regulatory requirements. The preferred method to prove conformity is the certification of the Quality Management System according ISO 9001 and/or ISO 13485, ISO 13488, or ISO 14971 by a Conformity Assessment Body (CAB).

Methodize Inc. is a consulting and training firm specializing in regulatory, clinical and quality services. We are your reliable source for certification and testing services, with over 35 years of combined Regulatory, Quality and Clinical services we have been helping companies all over the world in bringing medical devices and In-Vitro Diagnostics products to market.
In case, you need any assistance please get in contact with our team.

Clinical Trials in the US & EU

A clinical trial is a carefully designed research study that is carried out with human volunteers. The trial is designed to answer specific questions concerning the effectiveness of a drug, treatment, or diagnostic method, or to improve patients' quality of life. Qualification for a clinical trial involves the selection of various desirable criteria (inclusion criteria), as well as criteria by which volunteers are rejected (exclusion criteria). Typical criteria include age, gender, the type and severity of the disease, prior treatment, and other medical conditions.

Depending on the clinical trial, the volunteers that are recruited could be healthy or ill with the disease under study. There are different types of clinical trials that make use of differing types of study plans (protocols). A treatment trial evaluates a new treatment, new drug combinations, new surgical strategies, or original radiation therapy. A prevention trial seeks to find better ways to prevent disease from occurring or prevent disease from returning. Medicines, vaccines, vitamins, and lifestyle changes can all be strong components for an avoidance trial. An analytic trial is designed to find better means of diagnosis for a particular disease or medical condition. A screening trial is designed to determine the best way to become aware of a particular disease or medical condition. Finally, a quality of life trial (supportive care trial) seeks to improve the ease and daily life of people with a chronic sickness. Clinical trials, particularly treatment and prevention trials often have several components, or stages. A typical clinical trial involves medical doctors and nurses, although social workers and other health care workers.

Methodizeinc is the leading provider of health consulting services like pre-market assessment, protocol reviews, statistical strategies, sample size calculation, regulatory applications, IDE, 510(k) and PMA support, investigational site monitoring, data entry, statistical analysis, data management, final reports, investigational site audits, sponsor audits, medical device clinical research training in good clinical practices (GCP), clinical trials design, project management for clinical studies