Founded in 2013, Kounter Intuitive Technologies (KIT) started its journey with the sole purpose of providing regulatory consultation to the medical device companies. We navigate the manufacturers through the complex landscape of getting regulatory approvals from their targeted regulatory authority.
With a remarkable experience of 10 years, our team implements a highly customized approach and has the expertise in following standards:
• EU MDR 2017/745
• IVDR 2017/746
• FDA 21 CFR 820
• UKCA
• SFDA
• DRAP
Our services cover technical documentation of low-to-high risk (Class I – III) medical devices.
• Comprehensive technical file
• Device design and manufacturing
• Verification and validation
• Risk management plan and report
• Biocompatibility – BER, ISO 10993-1:2021
• Clinical evaluation – CEP, CER, literature search, vigilance search, references
• Packaging and labelling information
• Post-Market Surveillance (PMS) plan and report
• Quality management system (QMS) compliance - ISO 13485:2016, ISO 9001
Company Details
- Employees
- 9
- Founded
- -
- Address
- Office No.103 1st Floor Block-5 Lane-2 Times Square Commercial Bahria Town Phase 7, Rawalpindi,punjab 46620,pakistan
- Industry
- Legal Services
- NAICS
-
Legal ServicesOffices of NotariesOther Legal ServicesTitle Abstract and Settlement OfficesAll Other Legal Services
- Keywords
- Regulatory Approvals, Regulatory Consultant, Medical Device Regulations, QMS Compliance, Technical Documentation, ISO 13485, ISO 14971, ISO 10993, ISO 9001, EU MDR 2017/745, DRAP, IVDR 2017/746, SFDA, FDA 21 CFR 820, UKCA.
- HQ
- Rawalpindi, Punjab
- Competitors
- MaxHealth Hospital, Neureveal Inc | Democratizing Medical Innovation across the world!, NUST- School of Mechanical & Manufacturing Engineering, Medequips SMC, Revive Medical Technologies Inc., NextGen Research Consultancy, N-ovative Health Technologies Pvt Ltd, BlueMed Billing Services, Lifelab Testing™, McCarthy Learning (RTO#No.21960).
Kounter Intuitive Technologies Questions
Kounter Intuitive Technologies's website is http://kounterintuitivetechnologies.com
Kounter Intuitive Technologies's LinkedIn profile is https://pk.linkedin.com/company/kounter-intuitive-technologies
Kounter Intuitive Technologies has
9 employees.
View email and phone details for 9
employees at Kounter Intuitive Technologies.
Kounter Intuitive Technologies's industry is
Legal Services
Kounter Intuitive Technologies's top competitors are
Maxhealth Hospital,
Neureveal Inc | Democratizing Medical Innovation Across The World!,
Nust- School Of Mechanical & Manufacturing Engineering,
Medequips Smc,
Revive Medical Technologies Inc.,
Nextgen Research Consultancy,
N-Ovative Health Technologies Pvt Ltd,
Bluemed Billing Services,
Lifelab Testing™,
Mccarthy Learning (Rto#no.21960).
Kounter Intuitive Technologies's categories are Legal Services
Kounter Intuitive Technologies's founding year is 2016
