Are biocompatibility testing labs in India FDA accredited?

Many biocompatibility testing labs in India hold ISO 17025 accreditation and GLP certification, which are recognized by FDA for medical device testing. Some labs also have direct FDA inspection history. Always verify accreditation status and check if the lab has experience with FDA 510(k) submissions.

How much does biocompatibility testing cost in India?

Biocompatibility testing costs in India are typically 30-50% lower than US or EU labs due to lower operational costs. Basic test batteries (cytotoxicity, sensitization, irritation) range from $4,000-$10,000, while comprehensive testing for implants can cost $20,000-$40,000. Get quotes from multiple labs to compare pricing.

What ISO 10993 tests do Indian labs offer?

Leading biocompatibility testing labs in India offer the full range of ISO 10993 tests including cytotoxicity (ISO 10993-5), sensitization (ISO 10993-10), irritation (ISO 10993-23), systemic toxicity (ISO 10993-11), genotoxicity (ISO 10993-3), hemocompatibility (ISO 10993-4), implantation (ISO 10993-6), and chemical characterization (ISO 10993-18). Many labs also provide BEP/BER services.

How long does biocompatibility testing take in India?

Testing timelines in India are similar to global standards: basic test batteries take 6-10 weeks, while comprehensive testing for implants can take 20-36 weeks. The critical path is typically genotoxicity (8-12 weeks) or implantation studies (12-20 weeks). Some labs offer expedited services for an additional fee.

Do Indian labs accept international clients?

Yes, most accredited biocompatibility testing labs in India actively serve international clients, including US, EU, and other global medical device manufacturers. They are experienced with FDA 510(k), EU MDR, and other regulatory submissions. Many labs have dedicated international business teams and offer English-language communication.

What accreditations should I look for in Indian biocompatibility labs?

Look for ISO 17025 accreditation (testing laboratory competence), GLP certification (Good Laboratory Practice), and NABL (National Accreditation Board for Testing and Calibration Laboratories) accreditation. Some labs also hold international accreditations from bodies like A2LA or have FDA inspection history. Verify current accreditation status before engaging.

Biocompatibility Testing Labs in India

Find and compare ISO 10993 accredited biocompatibility testing labs in India. Get competitive quotes from verified Indian labs offering full test batteries for FDA 510(k), EU MDR, and global regulatory submissions. Cost-effective testing with international quality standards.

Browse All Biocompatibility Labs arrow_forward Get Quotes from Indian Labs request_quote

30-50%

Cost Savings vs US/EU Labs

ISO 17025

Accredited Labs Available

FDA

510(k) Submission Experience

EU MDR

Compliant Testing Services

Why Choose Biocompatibility Testing Labs in India?

India has emerged as a leading destination for biocompatibility testing, offering world-class facilities with significant cost advantages. Leading Indian labs combine international accreditation, experienced teams, and competitive pricing to deliver high-quality testing services.

savingsCost-Effective: 30-50% lower costs compared to US or EU labs without compromising quality
verifiedInternational Accreditation: ISO 17025, GLP, and NABL certified facilities
groupsExperienced Teams: Highly qualified scientists with decades of experience in medical device testing
languageGlobal Reach: Extensive experience with FDA 510(k), EU MDR, and other international submissions
scheduleFast Turnaround: Efficient processes and capacity for expedited testing when needed
support_agentEnglish Communication: Dedicated international business teams for seamless collaboration

Comprehensive ISO 10993 Testing Services

Leading biocompatibility testing labs in India offer the complete range of ISO 10993 tests required for medical device regulatory submissions:

scienceCytotoxicity Testing (ISO 10993-5): Cell viability and cytotoxicity assessment
scienceSensitization Testing (ISO 10993-10): Allergic reaction potential evaluation
scienceIrritation Testing (ISO 10993-23): Local tissue irritation assessment
scienceSystemic Toxicity (ISO 10993-11): Acute and subchronic systemic effects
scienceGenotoxicity (ISO 10993-3): Genetic damage potential evaluation
scienceHemocompatibility (ISO 10993-4): Blood compatibility testing
scienceImplantation (ISO 10993-6): Long-term tissue response evaluation
scienceChemical Characterization (ISO 10993-18): Extractables and leachables analysis

Many labs also provide Biological Evaluation Plans (BEP), Biological Evaluation Reports (BER), and toxicological risk assessment services to support your regulatory submissions.

Accreditation & Quality Standards

When selecting a biocompatibility testing lab in India, verify the following accreditations and certifications:

verifiedISO 17025: International standard for testing laboratory competence
verifiedGLP Certification: Good Laboratory Practice compliance for regulatory submissions
verifiedNABL Accreditation: National Accreditation Board for Testing and Calibration Laboratories (India)
verifiedFDA Inspection History: Some labs have direct FDA inspection experience
verifiedInternational Accreditations: A2LA, UKAS, or other recognized bodies

Quality Assurance: Leading Indian labs maintain rigorous quality management systems, participate in proficiency testing programs, and have established track records with FDA 510(k) and EU MDR submissions.

Cost & Pricing for Biocompatibility Testing in India

Biocompatibility testing costs in India are significantly lower than US or EU labs while maintaining equivalent quality standards:

attach_moneyBasic Test Battery: $4,000-$10,000 (cytotoxicity, sensitization, irritation)
attach_moneyStandard Test Battery: $12,000-$25,000 (includes genotoxicity, systemic toxicity)
attach_moneyComprehensive Testing: $20,000-$40,000 (full battery for implants)
attach_moneyChemical Characterization: $8,000-$20,000 (extractables and leachables)

Factors Affecting Cost: Test scope, device complexity, GLP requirements, turnaround time, and additional services (BEP/BER, toxicological risk assessment). Always request detailed quotes from multiple labs to compare pricing.

How to Choose the Right Lab in India

Selecting the right biocompatibility testing lab in India requires careful evaluation of several factors:

check_circleVerify Accreditations: Confirm current ISO 17025, GLP, and NABL status
check_circleCheck Experience: Review track record with your device type and regulatory pathway
check_circleEvaluate Capabilities: Ensure the lab offers all required ISO 10993 tests
check_circleCompare Pricing: Get detailed quotes from multiple labs for accurate comparison
check_circleAssess Communication: Evaluate responsiveness and English-language support
check_circleReview Turnaround Times: Confirm timelines align with your submission schedule
check_circleRequest References: Ask for case studies or client testimonials

Ready to Find Your Biocompatibility Testing Lab?

Compare verified biocompatibility testing labs in India. Browse profiles, read reviews, and request quotes from multiple accredited labs.

Browse All Labs search Get Multiple Quotes request_quote