All certification, regulatory approval, and quality documentation required for vendor evaluation, tender applications, and hospital formulary listing — searchable, current, and downloadable.
Last full review: 15 Mar 2025
✓ All documents current
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Download full compliance dossier
Bundled PDF containing all current certifications, regulatory approvals, quality documents, and the product recall history statement — formatted for tender submission. 68 documents · Updated 15 Mar 2025 · 24.4 MB
All Documents68
Certifications12
Regulatory Approvals9
Drug Licences6
Product Specifications22
Clinical Studies14
Quality Assurance8
Insurance & Liability3
Product recall history statement
MGRM Medicare Pvt Ltd confirms that as of 15 March 2025, no MGRM branded medical device or pharmaceutical product has been subject to a voluntary or regulatory recall in India or any international market in which MGRM operates. This statement is updated quarterly and signed by the Quality Director.
Signed: Dr Kavita Rao, Quality Director, MGRM Medicare Pvt Ltd · Ref: QA-STMT-2025-Q1 · Next review: 15 June 2025
No recalls
All compliance documents
68 documents
Document
Type
Issued
Valid until
Last updated
Actions
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ISO 13485:2016 — Quality Management System Certificate
Scope: Design, manufacture and distribution of medical devices. MGRM Medicare Pvt Ltd, Mumbai & Pune facilities.
Certificate
Jan 2024
Jan 2027 ✓
Updated 12 days ago
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CE Mark Declaration of Conformity — Rehabilitation Range
Licence no: MD-CDSCO-2023-MFG-4421. Class A & B medical devices. Facilities: Mumbai (Primary), Pune (Assembly). Issued by: Central Drugs Standard Control Organisation.
Reg. Approval
Mar 2023
Mar 2028 ✓
Updated 8 days ago
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CDSCO Wholesale Drug Licence — Pharmaceutical Range
Licence no: WDL-CDSCO-2022-PH-8814. Wholesale distribution of Schedule H and OTC pharmaceutical products. Issued under Drugs & Cosmetics Act 1940.
Good Manufacturing Practice certification for pharmaceutical products. Issued by: Directorate General of Health Services (on behalf of WHO). Facility: Mumbai pharmaceutical plant.
WHO-GMP
Jun 2023
Jun 2026 ✓
Updated 18 days ago
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FDA 510(k) Clearance — PulseView Pro Pulse Oximeter
K-number: K241789. Device class: Class II. Predicate device reference. Cleared for commercial distribution in United States. Date: Apr 2024. FDA CDRH.
FDA 510(k)
Apr 2024
No expiry ✓
Updated 12 days ago
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Product Test Report — ROM Knee Splint (MGRM-RS-ROM)
Third-party biocompatibility, mechanical performance and ROM accuracy testing. Testing lab: SGS India Pvt Ltd. Ref: SGS-2024-MED-0441. Tests per ISO 10993-1.
Test Report
Feb 2024
Feb 2027 ✓
Updated 30 days ago
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Product Liability Insurance Certificate
Policy no: PLI-2024-MGRM-0088. Insurer: HDFC Ergo General Insurance. Cover: ₹50 crore per occurrence, ₹100 crore annual aggregate. Covers medical device and pharmaceutical product liability.
Insurance
Apr 2024
Apr 2025 ✓
Updated 5 days ago
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Request a specific document
For tender authorities or procurement teams who need a document not in the standard library — MSDS for a specific product, a letter of authorization, country-specific regulatory filing, or a document in a specific format.
Response within 2 business days — your account manager will contact you directly.
Section 1 — Compliance Documentation CentreDossier download band (gradient card): Download all documents ZIP + Generate custom dossier. Section-level search + document type filter + validity filter. 7 document category tabs with counts. Pinned recall statement (Teal card, no recalls confirmed, signed + dated). Document list table: 8 columns (Document name + scope / Type badge / Issue date / Validity date + colour-coded / Freshness indicator / Actions). Expiring doc (CDSCO Drug Licence): amber validity + renewal note button. Request specific document form: purpose dropdown (6 options including government procurement and export).
8 document categories + recall statementFreshness indicator per rowValidity colour coding (green/amber/red)Download all + request specific doc
Peer-reviewed studies, RCTs, meta-analyses, and observational data supporting MGRM Medicare products. All papers are hyperlinked to their primary source. Clinical summaries available for each key study.
Filter:
All studies (14)
Rehabilitation (8)
Pharmaceuticals (3)
Healthcare Systems (3)
RCT
Observational
Meta-analysis
Systematic review
Post-surgical rehab
Arthritis & OA
Pain management
Clinical summaries — 1-page layperson-friendly study digests
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Clinical Summary · ROM Knee Splint
ROM Knee Splint in Post-TKR Rehabilitation: Clinical Evidence Summary (2024)
1-page clinician-validated summary of 2 RCTs and 1 meta-analysis. Includes primary outcome data, patient selection criteria, and clinical recommendations.
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Clinical Summary · FlexiCool Pain Gel
Topical NSAID vs Oral NSAID in Musculoskeletal Pain: Clinical Evidence Summary (2023)
Comparative summary of 3 RCTs examining topical diclofenac gel versus oral NSAIDs. Covers efficacy, safety profile, and patient population recommendations.
All studies — 14 papers
RCTRehabilitation2023 · n=180
Randomised controlled trial of adjustable ROM splint design on post-TKR rehabilitation outcomes: a 12-week multicentre study
Adjustable ROM splint vs fixed immobilisation · p<0.001
Post-TKR patients (n=180) randomised to adjustable ROM splint (0–120°, 5° increments) or fixed immobilisation. Primary outcome: knee flexion at 12 weeks. Secondary: VAS pain score, physiotherapy session count, 30-day readmission. Adjustable ROM group achieved superior flexion ROM, reduced pain, and required fewer physiotherapy sessions.
Observational cohortRehabilitation2022 · n=240
ACL reconstruction outcomes with progressive adjustable ROM splinting versus standard fixed protocol: retrospective cohort analysis
Indian Journal of Sports Medicine · Vol 9, Issue 1 · 2022 · IF: 2.1
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ROM Knee Splint (MGRM-RS-ROM)
Primary outcome
Return to sport: week 16 vs week 20
ROM splint protocol vs standard fixed splinting · p=0.003
Retrospective analysis of 240 post-ACL reconstruction patients at 3 orthopaedic centres. Patients using MGRM ROM splint (weekly progressive ROM increase protocol) compared to fixed splinting. Significantly earlier full weight-bearing, 90° flexion milestone, and return to sport in the adjustable ROM group.
RCTPharmaceuticals2023 · n=310
Topical diclofenac gel versus oral ibuprofen in acute musculoskeletal pain: a randomised double-blind controlled trial
Topical gel non-inferior to oral NSAID · Fewer GI adverse events
310 patients with acute musculoskeletal pain randomised to topical diclofenac 1% gel (TID) or oral ibuprofen 400mg (TID). Comparable VAS pain reduction at day 7, with significantly fewer gastrointestinal adverse events in the topical group. Topical administration produces localised therapeutic concentrations without systemic NSAID burden.
Home pulse oximetry monitoring in post-surgical recovery: systematic review and meta-analysis of outcomes across 18 studies
Journal of Digital Health · Vol 6, Issue 1 · 2024 · IF: 5.8
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PulseView Pro Oximeter (MGRM-PV-PRO)
Key finding
−34% unplanned readmission rate
Home SpO₂ monitoring vs standard follow-up in post-surgical patients
Systematic review of 18 studies (n=4,242) examining home pulse oximetry in post-surgical monitoring. Home oximetry associated with significantly reduced unplanned readmissions, earlier detection of hypoxaemic events, and improved patient satisfaction scores. Subgroup analysis supports use in TKR, THA, and cardiac surgery recovery.
Section 2 — Clinical Evidence LibrarySection search + filter row: product category pills (All / Rehabilitation / Pharmaceuticals / Healthcare Systems) + study type pills (RCT / Observational / Meta-analysis / Systematic review) + clinical indication pills + publication year dropdown. Clinical summary banner (2 featured 1-pagers). Evidence grid (2-col): each card: study type + category badges + title + journal + impact factor + product reference chip + key outcome stat card (Teal bg, primary outcome in large type) + 2-sentence abstract + DOI + download buttons (Full paper + Summary).
2-col evidence gridKey outcome stat per studyMulti-dimension filter (type + category + indication + year)Clinical summary 1-pager downloads
Institutional Portal › Clinical Resources › Training & Education
Product Training & Education
Clinical application guides, fitting videos, and continuing education materials for physiotherapists, orthopaedic nurses, and ward staff. All resources are clinically validated by MGRM's clinical advisory team.
Product application guides
View all 22 guides →
PDF guide
12 pages
Rehabilitation · Knee
ROM Knee Splint: clinical fitting guide and weekly adjustment protocol
Validated by: Dr Anand Mehta, Orthopaedic Surgeon · Feb 2025
Video + PDF
6:18 · 8 pages
Rehabilitation · Wrist & Hand
How to fit a dynamic wrist extension splint: clinical application guide
Validated by: Priti Shah, Senior Physiotherapist · Jan 2025
PDF guide
6 pages
Healthcare Systems · Diagnostics
PulseView Pro: clinical setup, calibration and documentation protocol for ward use
Validated by: MGRM Clinical Team · Mar 2025
Video + PDF
8:44 · 10 pages
Rehabilitation · Shoulder
Shoulder immobiliser sling: sizing, fitting and post-operative instructions for nursing staff
Validated by: MGRM Clinical Team · Dec 2024
PDF guide
9 pages
Pharmaceuticals
FlexiCool Pain Relief Gel: prescribing guide for physiotherapists — indications, contraindications and dosage
Validated by: Dr Anita Sharma, Pharmacist · Nov 2024
Video + PDF
11:22 · 14 pages
Rehabilitation · Back & Spine
Lumbar support belt application: sizing assessment and therapeutic positioning for clinical staff
Validated by: MGRM Clinical Team · Jan 2025
Training videos — clinical tone, patient model demonstrations
View all 16 videos →
6:18
ROM knee splint: complete fitting demonstration on patient model
Rehabilitation · Physiotherapist presenter
4:45
Dynamic wrist extension splint: fitting and progression protocol
Rehabilitation · Occupational Therapist
3:05
PulseView Pro: correct application and reading interpretation
Healthcare Systems · Clinical nurse trainer
8:22
Lumbar support: ward-level fitting assessment and patient instruction
Rehabilitation · Physiotherapist presenter
Continuing education — CPD-accredited modules
View all modules →
Evidence-based orthotic selection in post-surgical knee rehabilitation
For: Physiotherapists · Orthopaedic nurses
Selecting the right brace at each phase of TKR and ACL recovery — clinical decision framework with MGRM product integration.
2.0 CPD credits · Accredited: Indian Association of Physiotherapists
Topical analgesics in clinical practice: evidence, prescribing and patient selection
For: Physiotherapists · Pharmacists · GPs
Mechanism, evidence base, and prescribing guidelines for topical NSAIDs and analgesic gels — clinical case studies included.
1.5 CPD credits · Accredited: Pharmacy Council of India
Home monitoring in post-surgical care: SpO₂, BP and the telemedicine integration
For: Surgeons · Nurses · Discharge planners
Integrating home monitoring devices into discharge planning. Clinical protocols for when to escalate. Case studies from partner hospitals.
1.5 CPD credits · Accredited: NMC India
Upper limb splinting for neurological conditions: a clinical application workshop
For: Occupational therapists · Physiotherapists
Static vs dynamic splinting in radial nerve palsy, post-stroke wrist, and spinal cord injury. Includes case-based assessment framework.
3.0 CPD credits · Accredited: AIOTA
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Request on-site training — for Tier 2 & Tier 3 partners
MGRM clinical specialists visit your facility to train orthopaedic staff, physiotherapists, and ward nurses on product application, fitting, and clinical protocols. Available for large institutional partners.
Tier 2+ only
Your account manager will confirm availability and schedule within 3 business days.
Section 3 — Product Training & EducationThree sub-sections: (1) Product application guides (2-col × 3 grid): each guide card has 120px thumb (category-tinted), PDF/video badge, duration/page count, clinical validator attribution, Download + Watch/Preview actions. Mix of PDF-only and Video+PDF guides across all 3 product categories. (2) Training videos (4-col): clinical tone, patient model demonstrations, clinical presenter role noted. (3) Continuing education (2-col 4-item grid): module title + target audience + description + CPD credits + accrediting body. On-site training form (Tier 2+ gated): coordinator name, products, staff count, dates, format, requirements.
Sales materials, product imagery, point-of-sale displays, and co-branded template assets for authorised MGRM distributors and resellers. Available to Tier 2 and Tier 3 partners only.
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You are accessing this section as a Tier 2 Partner. All marketing collateral below is available to you. Co-branded template assets marked Tier 3 are visible but require Tier 3 partnership agreement to download. Learn about Tier 3 →
Tier 2 · Unlocked
Product brochures (PDF)
Designed for clinical and trade audiences. Available in English and Hindi. Updated quarterly.
View all 18 brochures →
PDF brochure
Rehabilitation Range — Institutional Brochure 2025
A4, 16 pages · English & Hindi · Updated Feb 2025
PDF brochure
Pharmaceutical Range — OTC & Schedule H Trade Brochure 2025
A4, 12 pages · English · Updated Jan 2025
PDF brochure
Healthcare Systems — Home Diagnostics Trade Brochure 2025
A4, 10 pages · English · Updated Mar 2025
Product images (high-resolution)
High-res product photography on white background. Commercial use permitted for authorised MGRM partners only. MGRM branding must remain visible.
View all 84 images →
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6000×4000
ROM Knee Splint M — Front view
TIFF · 18.4 MB · RGB
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6000×4000
ROM Knee Splint — 3/4 angle
TIFF · 16.2 MB · RGB
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6000×4000
PulseView Pro — Product view
TIFF · 12.8 MB · RGB
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5000×3500
FlexiCool Gel 200g — Pack shot
TIFF · 14.1 MB · RGB
Point-of-sale display materials
View all →
Print-ready PDF
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A2 Pharmacy Counter Poster — Rehabilitation Range
Print-ready PDF · CMYK · 3mm bleed · Updated Jan 2025
Print-ready PDF
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Counter Display Unit — Wobbler Set (6 designs)
Print-ready PDF · CMYK · Pharmacy and clinic use
Tier 3 only
🔒 Tier 3 required
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In-store digital display assets — animated banners
MP4 / GIF · Multiple aspect ratios · Digital signage
Co-branded template assets
MGRM-approved templates for co-branded use. All templates include MGRM logo placement guidelines and must be submitted for approval before printing or publishing.
Tier 2–3 · Approval required
PowerPoint
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Co-branded hospital sales presentation template
PowerPoint (.pptx) · 24 slides · MGRM + partner logo zones
All co-branded materials must be submitted to MGRM for approval before external use. Send final files to: marketing@mgrmmedicare.com with subject: Co-brand approval — [Your institution name]. Approval turnaround: 5 business days.
