Regulatory Consulting and Services
Managing risk for patient health and safety
Medical device regulations are becoming increasingly difficult. We can help you comply with local, regional, and global regulatory requirements affecting 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 experience in U.S. FDA, EUMDR, EUIVDR, CFDA, TGA, Health Canada, and other major global regulations. We assist our customers in summary technical documentation (STED) files, Clinical Evaluation Report (CER), Performance Evaluation Report (PER), Design Dossiers, 510(k), PMA, UDI, Remediation, CAPA Management, Gap Identification, Recommendation, and Implementation for DHF/Tech Files. We have extensive experience in Pathology, Chemistry and Immunodiagnostics, Transfusion Medicine, Cardiology, Orthopaedics, Spine, ENT, RPM, Trauma, Extremities, Radiology, and many more segments. We will get your products to market quickly and assist in maintaining your compliance status.
SARACA's experts will ensure you achieve your goals on time. We will be there when you need someone to assist you to answer questions from the regulatory body. 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 geography. SARACA helps you to prepare technical documentation, technical files, and design files.
Global Regulatory Strategy Services:
SARACA has a wide range of offerings for start-ups, small, medium, and large organizations. We work closely with you to provide efficient and effective services in the following areas.
- Global Regulatory assessment, planning, and strategy
- Traditional and special 510(k), Pre-Market Approval (PMA) preparation and submission
- Design Dossier preparation
- FDA, Notified Body, and ISO 13485 registrar audit preparation and participation
- Supplier and Internal Audits
- Design Controls implementation and completion of Design History Files
- Clinical Evaluation Reports
- Medical Device Reporting and Vigilance Reporting
- Labeling and Instructions for Use
- Promotional literature assessments including surgical techniques, brochures, and websites
- Remediation resulting in audits or inspections
- Training and Mentoring
- Due Diligence and Integration Planning
MDR/IVDR Tech Files Services:
Our regulatory expert's team works with you to make documentation ready for your product in Europe.
- Summary technical documentation (STED) files as per EU IVDR (2017/746) and EU MDR (2017/745), Manufacturer’s Incident Reports (MIR), and field safety actions and notices, and device-specific vigilance reporting per MEDDEV 2.12-1 rev. 8
- Notified Body selection
- Labeling and Instructions for Use
- Medical Device Reporting and Vigilance Reporting
- Manage compliance strategy and risks
- Develop and sustain a competitive advantage
- Protect your brand
- Our consultants can temporarily be an extension 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
- Summary of Post Market Surveillance
CER and PER Services:
We have strong expertise in writing clinical evaluation reports for all classes of medical devices. Our clinical experts have extensive experience in clinical writings on a variety of medical devices including Orthopaedics, spine, radiology, cardiology, and surgical instruments.
- Clinical Evaluation Reports and Literature Reviews per MEDDEV 2.7.1 revision
- MAUDE search and analysis
- State of art development
- IVDR Gap Assessment
- Risk and benefit analysis
- Expertise in PubMed, Embase, Google Scholar, and other popular databases
- Performance Evaluation Report (PER) Article 56 of the IVDR with focus on all three elements: scientific validity, analytical performance, and clinical performance
- Extensive experience in various segments including Pathology, Chemistry and Immunodiagnostics, Transfusion Medicine
- Technical writing of clinical documents like Analytical Performance reports, Clinical Performance reports, and Scientific Validity reports
CLIENT TESTIMONIALS
We work continuously to receive customer feedback to provide them unmatched value. Here is what they say about us.
“Toby has had a smooth journey with Saraca Solutions. They have provided us with both a highly experienced Quality Manager and a very energetic Quality Engineer. Specifically, I would like to thank Saraca for closing our NCs in a timely manner while simultaneously performing a gap analysis on our entire QMS. Additionally, in preparation for an upcoming ISO audit, Saraca performed an internal audit on all of our major Quality subsystems. Lastly, Saraca Solutions faced our 2017 ISO audit, hand in hand with our staff, at Toby headquarters. I appreciate the end to end support provided by Saraca Solutions. This magnitude of interaction is unique among engineering services companies in the area of medical devices."
"Saraca was extremely helpful to our Product Team’s understanding of the requirements of ISO 13485 by presenting it to them in a simple and effective manner. They have also done a commendable job in helping us to align our deliverables in-line with the ISO 13485 requirements. With their help, our team was able to understand & implement the ISO 13485:2016 requirements effectively within a short duration. Their planning and execution methodology is superb. Overall, we are very happy with the outcome of our association with Saraca Solutions."
“Our team has partnered well with SARACA Solutions as we continue the development process for submitting one of ENT products for 510(k) review with US FDA. They constructed and maintain a Design History. They are also working on Risk Analysis as defined by our Quality Management System. The SARACA team has shown the depth of their experience working in the industry while seamlessly integrating well with us. In addition, their methods of collaboration ensure effectively developing the documentation and processes for our product management.”
Case Studies
We have provided a few projects which we have executed for our customers. Please reach out to us for more details.
