Strengthening Regulatory Compliance and Excellence in In Vitro Diagnostics (IVDs)
IVD Regulatory Consulting & Engineering Services
SARACA Solutions is a global consulting and engineering partner supporting organizations across pharmaceuticals, medical devices, healthcare, and engineering. We provide integrated Regulatory, Quality, Scientific, Engineering, and Compliance Consulting Services to help IVD organizations strengthen regulatory readiness and achieve global market access.
Our end-to-end IVD support spans the complete product lifecycle—from product strategy, development, performance evaluation, technical documentation, and CE marking to regulatory submissions, post-market surveillance, and lifecycle management.
As a strategic IVD regulatory consulting partner, we support technical documentation, scientific validity, analytical and clinical performance evaluation, risk management, quality systems, labeling, UDI, EUDAMED, PMS/PMPF, and global regulatory submissions. Our services are aligned with applicable requirements and standards, including EU IVDR 2017/746, ISO 13485, ISO 14971, ISO 20916, FDA requirements, CLSI, IMDRF, MDCG, and relevant IEC standards.
EU IVDR (Regulation (EU) 2017/746) replaces the IVDD (98/79/EC) and establishes requirements for the safety, performance, clinical evidence, traceability, conformity assessment, and post-market surveillance of IVD devices. IVDs are classified into Class A, B, C, and D based on applicable risk-based classification rules. The IVDR also introduces expanded requirements for companion diagnostics, software, genetic testing, performance studies, UDI, and EUDAMED, supporting greater transparency and patient safety throughout the product lifecycle.
In-Vitro Diagnostic Medical Devices Segments
SARACA supports a broad range of IVD products and diagnostic technologies across laboratory, clinical, molecular, and point-of-care applications. Our expertise covers product development, engineering, regulatory, performance evaluation, quality, and lifecycle support.
Clinical Chemistry Devices
Hematology Analyzers
Immunoassay / Immunodiagnostic Devices
Molecular Diagnostic Devices
Microbiology Diagnostic Systems
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Point-of-Care Testing (POCT) Devices
Rapid Diagnostic Test Kits
Histopathology / Cytology Devices
Who We Serve
We partner with a diverse range of organizations across the life sciences industry, providing solutions to meet their regulatory requirements. Our expertise supports IVD innovators, Diagnostic kit companies, Molecular diagnostic companies, Point-of-care Testing (POCT) companies and contract manufacturers for IVD products.
IVD Device Manufacturers
Organizations designing, developing, and manufacturing in vitro diagnostic (IVD) devices and systems for clinical testing and disease diagnosis.
Diagnostic Kit Companies
Organizations developing and manufacturing diagnostic kits for disease detection and clinical testing.
Molecular Diagnostics Companies
Companies specializing in DNA, RNA, and genetic testing technologies for accurate disease diagnosis.
Point-of-Care Testing (POCT) Companies
Organizations producing rapid diagnostic devices for testing at or near the patient care site.
Contract Manufacturers (CMOs)
Companies providing outsourced manufacturing services for medical devices, IVDs, and diagnostic products.
Our Service Offerings
SARACA provides end-to-end IVD Product Development, Engineering, Regulatory, Clinical, Quality, and Post-Market services, supporting IVD products from concept and development through regulatory approval, commercialization, and lifecycle management.
IVD Product Development & Engineering
IVD Product Development & Engineering
We support the development and optimization of IVD instruments, assays, systems, and associated technologies.
Regulatory Affairs & Global Market Access
Regulatory Affairs & Global Market Access
We help organizations develop regulatory strategies and navigate market access requirements across major global markets.
Technical Documentation & Medical Writing
Technical Documentation & Medical Writing
Our regulatory and scientific teams support the development and remediation of submission-ready documentation.
Literature Review & Evidence Evaluation
Literature Review & Evidence Evaluation
We generate and evaluate scientific evidence to support regulatory submissions and ongoing product lifecycle requirements.
Performance Evaluation & Clinical Evidence
Performance Evaluation & Clinical Evidence
We support comprehensive evaluation of scientific validity, analytical performance, and clinical performance.
Risk Management & Quality Compliance
Risk Management & Quality Compliance
We help organizations establish and maintain risk-based processes supporting product safety, performance, and regulatory readiness.
Quality Management System (QMS)
Quality Management System (QMS)
We support organizations in establishing, improving, and maintaining effective medical device quality systems.
Post-Market, Labeling & UDI
Post-Market, Labeling & UDI
We support ongoing regulatory and product lifecycle activities after market introduction.
Training & Competency Development
Training & Competency Development
We provide targeted training programs to strengthen regulatory, quality, and technical capabilities.
Global Regulatory & Standards Expertise
Our IVD consulting services can support applicable regulatory and standards requirements across major global markets.
Our Expert Team
At, Saraca, we have a team of 50+ medical writers, regulatory affair professionals, and scientific professionals who have successfully supported the development, registration and lifecycle management of IVD products. Our Expert team have a wide experience in working with global IVD manufactures. Our team have a Comprehensive experience in managing and supporting over 100+ products across a wide spectrum of therapeutic areas. Our team possesses extensive experience in developing high-quality regulatory documentation including Performance Evaluation Report, Clinical Performance Report, Scientific Validity Report, Analytical Performance Report, Post Market Performance Follow-up Report, and Summary of safety and performance in accordance with EU IVDR 2017/746, and MDCG guidance documents. We support IVD manufacturers, Contract Research Organizations (CROs), and healthcare companies in preparing submission-ready documents that meet the requirements of regulatory authorities.
Our expert team has experience with a diverse range of products, including clinical chemistry devices, hematology analyzers, immunoassay / immunodiagnostic devices, molecular diagnostic devices, and microbiology diagnostic systems. We support IVD manufacturers across the complete product lifecycle with regulatory strategy, medical writing, compliance solutions, and commercialization support to bring products to market efficiently and successfully.
Project Range
Engineers with Domain Experience
Specialists in Global Regulations
Medical Writers
How We Work
Assessment & Gap Analysis
- Identify Gaps in the existing files
- Highlights risks, inefficiencies or missing information
Planning & Strategic Development
- Define clear objectives and timelines
- Determine resource, responsibilities and methodologies
Document Preparation & Execution
- Creation of required documents
- Update the existing files
Review & Compliance Verification
- Check alignment with regulatory, internal or client standards
- Identifies errors or gaps
- Necessary revisions and validations
Deliverable & Submission
- Finalization of documents
- Submission of document to Client
- Feedback Collection
Assessment & Gap Analysis
- Identify Gaps in the existing files
- Highlights risks, inefficiencies or missing information
Planning & Strategic Development
- Define clear objectives and timelines
- Determine resource, responsibilities and methodologies
Document Preparation & Execution
- Creation of required documents
- Update the existing files
Review & Compliance Verification
- Check alignment with regulatory, internal or client standards
- Identifies errors or gaps
- Necessary revisions and validations
Deliverable & Submission
- Finalization of documents
- Submission of document to Client
- Feedback Collection
