🏥 Medical Devices & Regulatory Compliance Services

Design Safe • Manufacture Compliant • Deliver Quality Healthcare

Overview

At SGQ INNOVATIONS, we help medical device manufacturers, suppliers, and innovators navigate complex regulatory, quality, and safety requirements — ensuring their products meet global standards for performance, reliability, and patient safety.

We support organizations in implementing ISO 13485-compliant Quality Management Systems (QMS), achieving CE, MDR, and USFDA approvals, and establishing risk-based, traceable, and audit-ready systems.

“Your innovation saves lives — our systems make it safe, compliant, and globally trusted.”

Our Core Medical Device Services

⚙️ 1️⃣ ISO 13485:2016 – Medical Device Quality Management Systems

We design and implement ISO 13485-compliant QMS frameworks to ensure product safety, traceability, and global market access.

Our Services Include:

QMS Gap Analysis & System Design
Quality Manual, SOP, and Record Development
Device Master File (DMF) & Technical Documentation Support
Risk Management (ISO 14971) Integration
Supplier Qualification & Control Systems
Internal Audits & Management Review Support
Certification & Regulatory Audit Readiness

Benefits:
✅ Robust product lifecycle control
✅ Audit-ready documentation
✅ Global certification recognition

🧩 2️⃣ EU MDR 2017/745 & IVDR 2017/746 Compliance

We help manufacturers and authorized representatives comply with the European Union Medical Device Regulations (MDR) and In Vitro Diagnostic Regulation (IVDR).

Our Expertise Covers:

Classification & Conformity Assessment Route Selection
Technical Documentation (Annex II & III)
General Safety & Performance Requirements (GSPR) Compliance
Clinical Evaluation & Post-Market Surveillance (PMS)
Vigilance, Trend Reporting & Periodic Safety Updates
Notified Body Liaison & Audit Support

Outcome:
✅ CE Marking Readiness
✅ Full traceability from design to distribution
✅ Streamlined EU market entry

🇺🇸 3️⃣ USFDA Compliance & 21 CFR Part 820 (QSR)

We assist medical device companies in aligning with USFDA Quality System Regulation (QSR) for the American market.

Services Include:

Design Controls (21 CFR 820.30)
Device Master Record (DMR) & Device History Record (DHR) Preparation
Process Validation & Supplier Controls
FDA 510(k) Submission Support (Class I, II, III Devices)
CAPA, Non-Conformance & Complaint Handling Systems
FDA Audit & Inspection Readiness

Benefits:
✅ Compliance with USFDA’s QSR framework
✅ Reduced regulatory risk
✅ Enhanced market credibility

🧠 4️⃣ Product Design, Risk & Validation Support

We integrate risk-based design and validation systems across the product lifecycle, ensuring performance and safety compliance.

Our Expertise Includes:

Design & Development Planning
Design Review, Verification & Validation (V&V)
Risk Management as per ISO 14971
Software Validation (IEC 62304)
Sterilization Validation (ISO 11135 / ISO 17665 / ISO 11137)
Biocompatibility & Clinical Validation Support

Outcome:
✅ Reliable product performance
✅ Documented traceability
✅ Regulatory-ready design controls

📦 5️⃣ CE Marking & Product Certification Support

We support clients in achieving CE marking under MDR and IVDR, ensuring full regulatory documentation and conformity.

Services Include:

CE Marking Route Selection (Annex IX, X, XI)
Preparation of Technical Files & Clinical Evaluation Reports
Risk Assessment & Validation Evidence Compilation
Labeling & UDI Compliance
Notified Body Audit Coordination

Applicable Standards:
ISO 13485 | MDR 2017/745 | IVDR 2017/746 | ISO 14971 | ISO 10993 | IEC 60601

🧾 6️⃣ GMP & Regulatory Compliance for India

We help organizations comply with Indian Medical Device Rules (MDR 2017) and CDSCO registration requirements.

Support Includes:

CDSCO Import & Manufacturing License Documentation
Site Master File & Device Master File Preparation
Schedule IV / V Documentation & Validation Records
BIS / ISO Certification Mapping for Class A–D Devices
Mock CDSCO / BIS Audits & CAPA Closure Support

🔍 7️⃣ Post-Market Surveillance & Vigilance Systems

We build Post-Market Surveillance (PMS) and Vigilance Systems that ensure ongoing product safety and regulatory compliance.

Services Include:

Complaint Handling & Trend Analysis
Post-Market Clinical Follow-up (PMCF) Plans
Periodic Safety Update Reports (PSUR)
Field Safety Corrective Action (FSCA) Management
Incident Reporting to Competent Authorities

Benefits:
✅ Strengthened regulatory trust
✅ Improved product lifecycle monitoring
✅ Data-driven safety insights

🧪 8️⃣ Training & Competency Development

We empower teams with technical and regulatory knowledge through structured, interactive training programs.

Programs Include:

ISO 13485 Internal Auditor Training
EU MDR / IVDR Awareness & Implementation
Risk Management (ISO 14971)
Design Control & Validation Essentials
GMP for Medical Devices (India MDR 2017)
CAPA, Audit & Regulatory Readiness Workshops

Why Choose SGQ INNOVATIONS

✅ Certified ISO 13485 / ISO 14971 / MDR / FDA Experts
✅ End-to-End Support – From design to certification and post-market
✅ Regulatory Coverage – EU, USFDA, India, GCC, ASEAN
✅ Integrated Systems Approach – QMS + Risk + Regulatory + ESG
✅ Cross-Sector Expertise – Diagnostics, Devices, Implants, Disposables
✅ Proven Track Record – 100% certification success across clients

Industries We Serve

💉 Medical Device Manufacturers – Implants, Instruments, Equipment
🧫 IVD & Diagnostic Kits – Laboratories & Testing Equipment
🏭 Disposable & Consumable Products – Syringes, Catheters, PPE, Gloves
🧴 Pharma–Device Combinations – Drug Delivery Systems
📦 Packaging & Sterile Barrier Systems – BRCGS, ISO 11607 Compliance

Our Promise

“Safe Devices. Trusted Systems. Global Compliance.”
SGQ INNOVATIONS ensures your medical devices meet every quality, safety, and regulatory requirement — helping you bring products to market faster, safer, and more confidently.