Tab
Industry

Medical Devices

We support medical device manufacturers from concept to post-launch — providing safety, compliance, and full lifecycle support that accelerates time to market.
Book a free consultation
About the 
Medical Devices
ISO 18562 series
EU MDR
Applicable FDA Guidance Documents
ISO 10993 Series
What does set us apart?

Our integrated expertise across chemistry, materials science, toxicology, and biocompatibility, delivering a uniquely comprehensive approach to safety and compliance.

Combined with global regulatory insight and full lifecycle support, we help bring products to market faster, saving time and resources without compromising quality.

For medical devices, our solutions span from materials selection, processing support, and performance prediction to preparing Biocompatibility Evaluation Plans (BEP), Materials Risk Assessments (MRA), Toxicological Risk Assessments (TRA), and Biological Evaluation Reports (BER). We also conduct failure analysis and recommend preventive measures.

Applicable Standards: ISO 10993 Series, ISO 18562 series, EU MDR, Applicable FDA Guidance Documents, and other vertical standards or Regional Guidance Documents

Industry
End-to-End Material Expertise to Accelerate Innovation and Compliance
Materials Science
  • Materials selections
  • Supply chain management
  • Performance prediction
  • Chemistry manufacturing, and controls (CMC)
  • Customised materials development
View
Details
Chemical Characterization
  • Materials/Devicerisk assessment (MRA)
  • Compositionalanalysis strategy
  • Materialsequivalency assessment
  • Materialsreverse-engineering
View
Details
Extractables / Leachables (E/L)
  •  Targeted & non-targeted study design
  •  Exhaustive, exaggerated, simulated study design
  •  E/L Protocol review
  • Toxicological risk assessment (TRA)
View
Details
Biocompatibility
  • Biological test/evaluation plan (BEP)
  • Biological/Material risk assessment (MRA)
  • Toxicological risk assessment (TRA)
  • Biological evaluation report (BER)
  • Implantation study design
  • Degradation risk assessment & study design

‍

View
Details
Toxicology Risk Assessment
  • Toxicological risk assessment (TRA)
  • Grouping & surrogate/analogue selection (Read-Across)
  • Toxicological equivalency evaluation
  • Predictive genotoxicity assessment
  • Predictive Carcinogenicity assessment

‍

‍

View
Details
Virtual Project Management
  • Liaise with biocompatibility test laboratories
  • Participate in internal project meeting
View
Details
Failure Analysis & CAPA
  • Root cause investigations
  • Solution investigation
  • CAPA
View
Details
Why Companies Choose Chemva
Unprecedented Expertise Matters
98
%
Client Trust & Timely Delivery
On-time Delivery and Client Recommendation Rate
100
%
Sponsor Confidence
Complete sponsor satisfaction during interactions with global regulatory agencies.
7
Technical Committees.
Shaping the Future of ISO 10993 Standards as Industry Experts
75
+
BEPs and BERs Delivered
Biological Evaluation Plans and Reports supporting device safety and compliance.
80
+
Risk Assessments Prepared
Comprehensive Materials and Biological Risk Assessments (MRA) prepared to support product development.
55
+
TRA and E&L Studies Completed
Extractable/Leachable studies and Toxicological Risk Assessments delivered for high-risk materials.
Diverse Expertise. Proven Impact.

Medical Devices We’ve Helped Bring to Life

Orthopedics
  • Metallic and ceramic implants
  • Biodegradable orthopedic implants
Cardiovascular
  • Vascular stents and grafts
  • Artificial Tissues
  • Catheters, guidewires, delivery devices
Wearables and Digital Health
  • Biosensors and wearable monitors (i.e., continuous glucose monitor)
  • Drug delivery patches

‍

Wound Care
  • Advanced wound dressings (i.e., hydrogels, in-situ polymerizing systems)
  • Blood-clotting systems (i.e., resorbable hemostats)
  • Adhesion reduction materials.

‍

Neurology and Neurostimulation
  • Implantable Neurostimulators for pain management
Ophthalmology
  • Intraocular lenses
  • Ocular implants and drug delivery systems
Dental Devices
  • Dental implants
  • Dental surgical tools
Respiratory Care
  • Ventilators and respiratory support devices
  • Anesthesia Delivery Systems
  • Patient Monitoring Systems
Women’s Health
  • Implantable contraceptive devices
  • Resorbable contraceptive devices
  • Delivery devices
Urology
  • Urinary catheters and stents
  • Urological implants (i.e., penile implant, bladder stimulator)
How We Help Life Sciences & Healthcare Clients
We support life sciences clients across the full product lifecycle, helping bring therapeutics to market and improve outcomes. With science-based strategies, we solve regulatory, safety, and design challenges.
Let’s Partner together
CHEMVA
Proven Results
Real-World Insights From Complex Projects
Learn about our scientific approach that helps clients.
Biocompatibility
Biological Evaluation Plan (BEP) for a Next-Generation Implantable Device
Developed a risk-based BEP to meet FDA and ISO 10993-1 standards, helping the client avoid delays and save $300K through targeted testing.
Biocompatibility
Medical Devices; Combination Products; Drug Products
View
Details
Biocompatibility
Connectors Cracking: A Root Cause Analysis and Material Selection Effort
Chemva’s systematic approach not only resolved the cracking issue but also enhanced the product’s long-term reliability and manufacturability.
Materials, Failure Analysis & CAPA
Medical Devices; Combination Products; Drug Products, Personal Care Products
View
Details
View all case studies
Consulting. Collaborating. Catalyzing.
Accelerating innovation through expert solutions, teamwork, and education.
Book a free consultation