Key Compliance Issues for Medical Device Companies

Patient and medical device safety and medical device efficaciousness are the utmost priority. Throughout the past year, we've seen the highest two medical device markets’ health agencies either progressing to adopt or adopting new laws in a shot to stay pace with innovation.

New or updated medical device compliance—from the international organization for Standardization (ISO), the eu Union, and a gaggle of countries that have adopted the Medical Device Single program (MDSAP)—are focalization compliance needs for the medical technology business. With new deadlines coming back into result, firms should arrange currently to avoid risks and seize opportunities.

What does quality and compliance mean?

Quality and compliance are both crucial components of the manufacturing process; but, it's important to differentiate the two. Quality is defined as products and services that deliver intended performance, while compliance is defined as meeting regulatory requirements.

What is FDA compliance?

The FDA has legal authority to assure compliance with the Federal Food, Drug and Cosmetic Act of 1938, which replaced the Pure Food and Drugs Act. FDA field offices regularly perform inspections, conduct investigations and collect samples to ensure that products and companies are compliant with the laws.

What are regulatory compliance requirements?

Regulatory compliance is an organization's adherence to laws, regulations, guidelines and specifications relevant to its business processes. Violations of regulatory compliance regulations often result in legal punishment including federal fines.

Who regulates medical devices in the US?

In the United States of America, Medical Devices are regulated by Food and Drug Administration (FDA). FDA's Centre for Devices and Radiological Health (CDRH) is responsible for regulating firms who manufacture, repackage, re-label, and/or import medical devices sold in the United States.

Plianced offer medical device compliance training and certification program for professionals responsible for compliance. This course explains new collaborative initiatives that CDRH's Office of Compliance is launching with industry regarding medical device quality. Plianced medical devices compliance programs cover topics from quality and manufacturing concerns to product design, clinical trials, validation and regulatory filings. We provide Compliance Training through Webinars and Seminars on FDA Regulations, 510K, CAPA, PMA, MDR, Part 11 & more.