Medical Device Service Areas
Milestone Pharma offers a one-stop testing service covering the entire lifecycle of medical devices, focusing on five key areas: packaging validation, materials science research, drug development, process validation, and registration consulting. These services empower products with compliance and innovation throughout their journey from R&D to market launch.
1. For liquid-contact devices with packaging (e.g., infusion devices), leveraging a million-level extractable database and advanced technologies such as vacuum decay testing and helium mass spectrometry (sensitivity up to 10⁻¹ atm cc/sec), we conduct packaging compatibility, seal integrity, and transportation simulation verification.
2. For Class III implantable devices (e.g., titanium alloy bone screws, biodegradable sutures, bone cement), we offer chemical characterization, in vitro degradation analysis, and material equivalence assessment. Using high-resolution mass spectrometry and SEM-EDS technology to replace animal testing, we support NMPA approval in a single submission.
3. For combination drug-device products (e.g., paclitaxel-coated stents), we have developed a unique "three-stage release model" to simultaneously verify drug degradation and device shelf life.
4. Through AAMI TIR30 cleaning validation, microbial burden detection, and EO/ECH residue analysis, we ensure the safety of reusable devices and sterile products.
5. We also provide full-process registration consulting and GMP system establishment services for FDA, CE MDR, and NMPA. Leveraging our dual-certified CNAS/CMA laboratory network and regulatory recognition in China, the U.S., and Europe, we accelerate global market access. Milestone Pharma has successfully supported multiple medical device varieties in obtaining U.S. FDA 510(k) approvals and new EU CE MDR certifications.
Core Corporate Data
Laboratory area: Over 10,000 m²
Equipment input: 1.5 billion
Master-PhD ratio: Over 40%
Global users: 2,500+
Service items completed: 10,000+
Capabilities and Solutions
Packaging Validation Services
Material Compatibility (E&L study)
Applicable to: Disposable injection systems, infusion devices, pharmaceutical glass bottles, elastomeric seals
Provides material migration risk and safety assessments for liquid-contact devices with packaging to ensure compliance with global regulations.
Package Integrity
Applicable to: Sterilized surgical instruments, stent packaging, artificial heart valve packaging
For all packaged medical devices, verifies the integrity of the sterile barrier using vacuum decay testing and helium mass spectrometry.
Packaging Validation (Transport Simulation)
Applicable to: Rigid ophthalmic lens packaging, orthopedic implant transportation packaging
Simulates transportation vibration, extreme temperature and humidity conditions to verify the reliability of the packaging system throughout its lifecycle.
Materials Research Services
Chemical Characterization
Applicable to: Titanium alloy bone screws, high molecular weight artificial blood vessels, bone cement
Targets Class III implantable devices and high-risk devices, analyzes material composition, and evaluates chemical safety (ISO 10993-18).
Physical Characterization
Applicable to: Metal bone plates, biodegradable sutures, biodegradable magnesium alloy vascular stents
Analyzes the mechanical properties, surface morphology, and microstructure of Class III implantable devices to support design optimization.
In Vitro Degradation
Applicable to: Polylactic acid (PLA) bone fixation materials, collagen protein stents
Evaluates the degradation rate and product safety of degradable implantable devices, in compliance with GB/T 16886 series standards.
Component Analysis and Physicochemical Analysis
Applicable to: Stainless steel surgical instruments, silicone catheters
Uses techniques such as SEM-EDS and FTIR to accurately analyze the physical and chemical properties of metals, polymers, and other materials.
Material Equivalence Analysis
Applicable to: Novel polymer artificial joints, improved coating vascular stents
Compares the performance differences between new and old materials to support change submissions and regulatory compliance.
Drug-Device Combination Services
Drug Compatibility (Adsorption)
Applicable to: Insulin pump tubing, chemotherapy drug infusion systems
Detects the adsorption effects of infusion devices and other drug-contacting instruments to ensure drug stability.
Drug Stability and Release
Applicable to: Paclitaxel-coated coronary artery stents, antibiotic bone cement
Analyzes the release kinetics of drugs from device carriers to optimize targeted therapeutic effects.
Validation Services
Cleaning Validation
Applicable to: Laparoscopes, dental drill bits, ultrasound probes
Based on AAMI TIR30 standards, verifies the effectiveness of contaminant removal for reusable instruments (e.g., endoscopes).
Reuse Validation
Applicable to: Anesthesia machine circuits, extracorporeal circulation tubing
Evaluates the performance degradation and safety of instruments after multiple uses to reduce clinical risks.
Microbial Load Testing
Applicable to: Medical catheters, surgical sutures
Detects microbial contamination levels during the production process of medical devices to ensure sterile control.
Sterility Testing
Applicable to: Sterile gauze, pre-filled vaccine syringes
Verifies the effectiveness of sterilization processes through culture medium filling and biological indicator challenge tests.
Residual Disinfectant Detection
Applicable to: Single-use surgical gloves, medical catheters
Precisely analyzes residual amounts of ethylene oxide and 2-chloroethanol, complying with ISO 10993-7 limits.
Registration Consultation Services
Registration Consultation
Applicable to: In vitro diagnostic reagent manufacturers, implantable device manufacturers
Provides comprehensive strategies and technical document support for FDA 510(k), CE MDR, and NMPA registration processes.
GMP System Consultation
Applicable to: In vitro diagnostic reagent manufacturers, implantable device manufacturers
Establishes a quality management system compliant with FDA 21 CFR Part 820 and ISO 13485 to enhance production compliance.
Professional Teams
Packaging Validation Expert Team
15 years of packaging validation experience, capable of leading the verification of sterile barrier systems, with expertise in designing accelerated aging test schemes for high-risk implantable devices (ASTM F1980). Developed helium mass spectrometry leak detection with sensitivity up to 0.01 cc/min, serving precision instruments such as staplers and pre-filled syringes.
Materials Science Expert Team
Equipped with materials science PhDs, establishing multiple material databases. Possesses reverse engineering experience in polymer materials and surface analysis capabilities.
Chemical Analysis Expert Team
Experienced in constructing fingerprint libraries for material degradation products, successfully developing testing capabilities for trace substances at ppt levels. Cross-contamination assessment for medical device and pharmaceutical packaging E&L.
Toxicology Assessment Expert Team
Certified in three locations: ERT, DABT, and DCST, completing multiple assessments of degradable and implantable system toxicity. Provides rapid reconstruction services for biocompatibility evidence chains for CE MDR transition products.
Pharmaceutical and Medical Device Combination Services Expert Group
Senior pharmaceutical development experts, establishing predictive models for drug-polymer compatibility. Focus on complex products such as drug-coated stents and drug-loaded microspheres, completing multiple combination product submissions.
Industry and Customer Recognition
Association and Standard Participation
· Member of the China Pharmaceutical Packaging Association
· Jiangsu Pharmaceutical Packaging and Excipients Association Member
· Member of the Chinese Expert Group for the Annual Meeting on Extraction and Dissolution Products (E&L)
· Participated in the formulation of the "Technical Regulations for Extractables from Single-Use Polymer Components in Pharmaceutical Manufacturing Processes"
· Drafting unit for the "Technical Guidance Principles for Compatibility Studies of Chemical Drugs and Elastomeric Seals (Trial)"
· Contributed to the compilation of the "FDA Warning Letter Compilation" (2022 Edition, 2023 Edition)
· Organized professional device seminars multiple times and participated in various industry forums of device associations for regulatory interpretation and case sharing
Official Recognition
· Nanjing laboratory passed FDA on-site inspection
· Shanghai laboratory passed FDA on-site inspection
· CNAS accreditation - Nanjing Mingjie, CNAS L11112
· CNAS accreditation - Shanghai Mingjie, CNAS L17395
· BSL-2 registration certificate (No. 022023031)
· National High-Tech Enterprise
· Shanghai Specialized, Sophisticated, Characteristic, and Innovative Enterprises
· Nanjing "Gazelle Enterprise" and "Unicorn Incubation" Enterprise
· Jiangsu Integrated Quality Control Engineering Technology Research Center for Pharmaceuticals
Timeliness & Technical Recognition
Timeliness recognition: MingSwift™ registration service, efficiently completes urgent projects in a short time
Technical recognition: Obtained FDA 510(k) certification in as fast as 7 days, successfully registered multiple CE MDR device projects
