Given the safety-critical nature of medical devices, regulatory compliance is one of the biggest roadblocks for medical device manufacturers in bringing their products in a faster timeframe.
The main areas where medical device manufacturers face a problem are:
- Lack of specialized expertise in regulatory compliance (especially in case of startups)
- Shortage of resource bandwidth to dedicate to full-time regulatory compliance activities
- Keeping abreast of new developments in the regulatory compliance space
- Ensuring regulatory compliance across multiple geographies for international products
Wipro has a dedicated practice for medical device regulatory compliance and quality consulting. We are ISO 13485 certified for design, development, conversion, maintenance and testing of customized software and hardware for medical devices. We have process conformance to ANSI/AAMI SW68 / IEC 62304 standards.
Wipro's framework-based regulatory compliance solutions help medical devices manufacturers in the following ways:
- As an extended team - Wipro become the regulatory compliance department for customers and handles all regulatory aspects for them.
- As a support team - Wipro shares and supports regulatory compliance work for customers.
- Handle dynamic changes in regulatory compliance standards - Wipro removes overhead for the customer by adapting processes to the changes in standards
The following are the regulatory compliance solutions that Wipro offers to medical device manufacturers:
- Medical equipment evaluation, testing, compliance test reports preparation across geographies
- Medical safety certifications - UL, TUV, CSA, etc.
- Medical device construction change
- Compliance engineering consulting
- Evaluation/testing for FDA 510(k) submission and clinical trials
- CE marking assistance
- Quality consulting
- Risk Management (ISO 14971:2007) consulting
- Regulatory compliance training and seminars
Wipro delivers sophisticated IT integration solutions compliant with necessary industry guidelines and aligned to your business requirements. Our solutions incorporate,
- 21 CFR Part 11 Compliance: Wipro leverages its extensive experience in 21 CFR Part 11 implementation in new as well as existing systems to provide consultancy services like gap analysis, risk assessment and remediation plans.
- Computer System Validation : The Wipro Computer System Validation methodology centers on the FDA and GAMP4 computer validation guidance. Our focus is to enable seamless regulatory compliance to minimize risk and optimize your IT investments.