Regulatory Consulting and Services

The medical device regulations are becoming increasingly difficult in recent times. We can help your company comply with local, regional, and global regulatory requirements that affect your products. All major regulations have their own specific requirements, although there are harmonized essential requirements that are valid in each country. We have extensive experienced in FDA, EUMDR, CFDA, TGA, Health canada, and other major global regulations. We assist our customers in Design Dossiers, 510 (K), PMA, UDI, Remediation, CAPA Management, Gap Identification, Recommendation and Implementation for DHF/Tech Files for Orthopaedics, Spine, ENT, RPM, Trauma, Extremities, Radiology, Pathology, Cardiology, and many more segments. We will get your products to market quickly and assist to maintain your compliance status.

Regulatory Services:

SARACA has wide range of offering for start-ups, small, medium and large organizations. We work closely with you staff and provide efficient and effective services

  • Consulting services for management systems certification
  • FDA,TGA,CFDA,Health Canada,EU MDR Regulatory Strategic Planning
  • Gap Analysis and action implementation
  • Developing regulatory strategy and submissions
  • Identification of applicable regulatory requirements
  • Providing product safety and efficacy evaluations
  • Third-party technical liaison
  • 510 (k), PMA, Design Dossier Preparation
  • Notified Body Selection
  • Post Market Surveillance (PMS) and Clinical evaluation report (CER)

SARACA Benefits:

SARACA's experts with ensure you achieve you goals in time. We will be there when you need someone to assist you to answer questions from the regulatory body.

  • Manage compliance strategy and risks
  • Develop and sustain a competitive advantage
  • Protect your brand
  • Our consultant temporarily be part of your team to manage regulatory compliance issues
  • Minimize business impacts such as loss of sales, product recall, and obsolete inventory
  • Support reporting incidents and field actions in the US, Europe and other markets

In order to build or stay in compliance you will have to create or update technical documentation. A Notified Body or a regulatory body will review your technical documentation and verify if it complies with the medical device regulations for a particular geography. SARACA helps you to prepare technical documentation, technical files and design files.