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Submissions

Submissions

FDA Regulatory Pathways and Submission Types Some of the pathways to market you may not have heard much about. Special 510(K) Traditional 510(k) Abbreviated 510(k) PMA and PMA supplements HDE/HUD De Novo Combination Product – Read more in SPECIALTY SERVICES Investigational Device studies may... Read More

Design Control and Review

Design Control and Review

Design Control Reduce costs and time to market with efficient development systems All successful regulatory submissions are supported by FDA compliant Design Control and Review systems. Quality System Regulations (21 CFR 820 :QSRs) and ISO 13485 require documented design review according to... Read More

Qualification Planning and Testing

Qualification Planning and Testing

Qualification Planning and Testing requires coordination of the development of protocols with product claims, risk mitigation and performance requirements. Qualification planning pulls together Design Control compliance, regulatory submission requirements, such as development of claims,... Read More

Compliance

Compliance

Quality System compliance monitoring has increased by both the US FDA & by the foreign competent authorities & their agencies. Keeping up with best practices is time-consuming. We have the experience to train your staff, & serve as your interface with FDA if needed. We can conduct a Quality... Read More

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