Saraca Solutions

Future-Ready Engineering Solutions. Precision. Innovation. Delivered.

SARACA Solutions is an ISO 13485 certified medical device engineering services company delivering innovative, cost-effective solutions with a strong commitment to customer satisfaction, quality, and regulatory compliance. Our multidisciplinary team—comprising quality and regulatory engineers, software developers and testers, and embedded electronics and electrical engineers—brings deep expertise across Quality Management Systems (QMS), concept design, Design of Experiments (DOE), Pugh matrix evaluations, risk analysis, and risk management.
We have extensive experience operating in highly regulated medical device environments, including U.S. FDA and European regulatory frameworks. Our teams are well-versed in ISO 13485:2016, FDA Quality Management System Regulation (QMSR – 21 CFR Part 820, aligned with ISO 13485), ISO 14971:2019, and IEC 62304:2006 + AMD 1:2015 for medical device software lifecycle processes.
Our capabilities span the entire product lifecycle, including development, review, and remediation of Design History Files (DHF) and EU Technical Documentation, 510(k) submissions, UDI implementation, CAPA management, and remediation activities for Class I, II, and III medical devices, including software-based and software-driven products.
Quality Management System (QMS) Services
SARACA Solutions supports the establishment, enhancement, and maintenance of robust QMS frameworks through the following services:
Development of new QMS or adaptation of existing QMS aligned with ISO 13485:2016, FDA QMSR (21 CFR Part 820), and IEC 62304
Extension of existing QMS to support Software as a Medical Device (SaMD)
QMS gap analysis to identify compliance gaps and improvement opportunities
DHF, Risk Management File (RMF), and EU MDR Technical Documentation remediation and gap closure
QMS implementation or upgrades to meet ISO 13485:2016, FDA QMSR, and EU MDR (Regulation (EU) 2017/745)
Process review and optimization to improve compliance, operational efficiency, and inspection readiness
Compliance support for:
ISO 14971:2019 – Risk Management
IEC 62304:2006 + AMD 1:2015 – Medical Device Software Lifecycle
IEC 60601-1 Edition 3.2 (2020 + A1:2020) – Medical Electrical Equipment
Active support during U.S. FDA inspections and Notified Body (NB) audits

Company Details

Address

16192 Coastal Highway

Lewes, DE 19958

Phone

Website www.saracasolutions.com

Published: 1/29/2026 →

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Saraca Solutions

Company Details

Products & Services

Performance Evaluation Report (PER)

Clinical Evaluation Report (CER)

Software Quality Assurance

EU MDR & EU IVDR Compliance Services

Quality Assurance Services - Implementation & Compliance support

Regulatory Affairs Consulting

Post Market Surveillance

Risk Management & Biocompatibility Services

Mechanical Design

News & Press Releases

Best way to write a Clinical Evaluation Report (CER) in 2026 following latest MDCG guidelines

The Performance Evaluation Report (PER) Per (EU) 2017/746

Challenges in writing Clinical Evaluation Reports

PFAS Compliance in Medical Devices: A Regulatory Imperative for Manufacturers

How Medical Device Engineering Solutions Support Safer and Compliant Products

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