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Industry

Medical Devices Page

End-to-End Support for Safer, Smarter, Life-ChangingMedical Devices
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About the Medical Devices
ISO 10993 Series
ISO 18562 series
EU MDR
Applicable FDA Guidance Documents
We supportmedical device manufacturers from concept to post-launch.
Whatdoes 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
Solutions for Medical Devices
01
Materials Science
  1. Materials selections
  2. Supply chain management
  3. Performance prediction
  4. Chemistry manufacturing, and controls (CMC)
  5. Customised materials development
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02
Chemical Characterization
  1. Materials/Device risk assessment (MRA)
  2. Compositional analysis strategy
  3. Materials equivalency assessment
  4. Materials reverse-engineering
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03
Extractable & Leachable
  1. Targeted & non-targeted study design
  2. Exhaustive, exaggerated, simulated study design
  3. E/L Protocol review
  4. Toxicological risk assessment (TRA)
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Details
04
Biocompatibility
  1. Biological test/evaluation plan (BEP)
  2. Biological/Material risk assessment (MRA)
  3. Toxicological risk assessment (TRA)
  4. Biological evaluation report (BER)
  5. Implantation study design
  6. Degradation risk assessment & study design
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05
Toxicological Risk Assessment
  1. Toxicological risk assessment (TRA)
  2. Grouping & surrogate/analogue selection (Read-Across)
  3. Toxicological equivalency evaluation
  4. Predictive genotoxicity assessment
  5. Predictive Carcinogenicity assessment
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06
Virtual Project Management
  1. Liaise with biocompatibility test laboratories
  2. Participate in internal project meeting
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07
Failure Analysis & CAPA
  1. Root cause investigations
  2. Solution investigation
  3. CAPA
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Why Companies Choose Chemva
Unprecedented Expertise Matters
98
%
Client Trust & Timely Delivery
On-time Delivery and Client Recommendation Rate
100
%
Sponsor Confidence
Sponsor Satisfaction During Discussions with Regulatory Agencies
7
Technical Committees.
Developing ISO 10993 Standards in the US and Globally 
75
+
BEPs and BERs Delivered
Biological Evaluation Plans (BEP) and Reports (BER) Delivered
80
+
Risk Assessments Prepared
Materials/Biological Risk Assessments (MRA) Prepared
55
+
TRA and E&L Studies Completed
Extractable/Leachable (E&L) Studies Designed and Toxicological Risk Assessments (TRA) Delivered
Orthopedics (01)
  • Metallic and ceramic Implants 
  • Biodegradable orthopedic implants
Cardiovascular (02)
  • Vascular stents and grafts
  • Artificial Tissues 
  • Catheters, guidewires, delivery devices 
Wearables and Digital Health (03)
  • Biosensors and wearable monitors (i.e., continuous glucose monitor) 
  • Drug delivery patches
Wound Care (04)
  • Advanced wound dressings (i.e., hydrogels, in-situ polymerizing systems)
  • Blood-clotting systems (i.e., resorbable hemostats)
  • Adhesion reduction materials
Neurology and Neurostimulation (05)
  • Implantable Neurostimulators for pain management
Ophthalmology  (06)
  • Intraocular lenses
  • Ocular implants and drug delivery systems
Dental Devices (07)
  • Dental implants
  • Dental surgical tools
Respiratory Care (08)
  • Ventilators and respiratory support devices
  • Anesthesia Delivery Systems
  • Patient Monitoring Systems
Women’s Health  (09)
  • Implantable contraceptive devices
  • Resorbable contraceptive devices
  • Delivery devices
Urology  (10)
  • Urinary catheters and stents 
  • Urological implants (i.e., penile implant, bladder stimulator)
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Devices

Across specialties and technologies, Chemva has guided medical device innovations from concept to patient care. Examples of our collaboration include:

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.
Material Section
Testing
Extractables
and
Leachables
Quality Control
Supply Chain Menegment
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Accelerating innovation through expert solutions, teamwork, and education.
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