Regulatory Compliance & Standards
The United States regulatory environment for the Government, Healthcare and Medical technology industries is a robust one with well laid out standards and best practices and sometimes cumbersome and complex requirements. These regulatory mandates are being evaluated and modified today to accommodate the changes affected by technology within these industries. FDA, HIPAA, ICD, ARRA, HITECH and many others have a major role to play in these industries. It is now up to the participants in these industries to understand and leverage them to their business advantage.
The vast number of guidelines or standards issued for effective healthcare compliance programs makes it difficult for developing, implementing and measuring an effective compliance program. There are solutions in the market, but these have to be tuned to your business requirements as organizations need to conduct ongoing auditing and monitoring of the health care compliance programs to ensure effectiveness.
Meet your Regulatory Compliance needs
Netspective can help medical device manufacturers and healthcare organizations with a variety of regulatory compliance issues. We can assist you with quality assurance, US regulatory compliance and incorporation of numerous standards and procedures. Our team of specialized consultants have hands-on experience helping hundreds of companies obtain the regulatory seal of approval to sell their medical devices and be compliant in the US. These experts are on top of the latest medical technology and healthcare regulatory requirements and guidance and can offer broad insight into market access, strategic compliance and safety. Our experts are on the regulatory advisory board and can provide you with a unique perspective to address your compliance needs.
Our approach is to engage with the development teams right from the development stage to help understand the regulatory landscape for your medical technology application needs and provide a fully integrated approach to technology development including design controls, communicating with regulatory authorities and post- product launch compliance support.
- Regulatory Classifications, Applications and Submissions
- 510(k), PMA, IDE, CE-marking
- Regulatory Liaison and Response
- Medical Communications
- Human Factors Engineering
- Strategy Compliance and Risk Management
- Quality Systems
- Independent Third-Party and due diligence audits
- Validation Solutions
- Ensure Meaningful Use Compliance
Get a Head Start to being Compliant with Netspective
Netspective focuses on understanding the organization, its competitive market landscape and mapping the regulatory compliance or standards to the organization’s need by providing expertise in existing and new legislation. We also analyze the benefits and risks involved so as to make informed decisions while developing a regulatory approach for the Healthcare and Medical technology enterprises.
The benefits achieved from Netspective’s services include knowledge of upcoming regulatory compliance requirements and standards giving you a head start to plan your strategic initiatives early on reducing time and cost to market. Most importantly we help with improving the quality metrics and reducing liability and risk due to non-compliance and operational errors.