Regulatory affairs

Verotech Solutions (VTS) technical operation team specializes in providing regulatory consulting services to their clients who are medical device manufacturers. We have a dedicated team working with our clients in regulatory strategy, preparation of FDA submissions, product manufacturing and testing, clinical trials set up and data collection and maintaining quality compliance.

Regulatory Services Provided:

FDA Regulatory Compliance Strategy
Premarketing Clearance 510(k) Submissions
Device Classifications and Product Listings
510(k) Exemptions
FDA Biocompatibility Requirements
Mock FDA Audits
Warning letter (Form 483) Responses & Activities
International Import/Export Issues
Regulations for packaging and labeling

Quality System Implementation

Our Team will provide valuable and informed insight for developing and implementing their client’s comprehensive quality plan.

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Medical Device

Successfully validating a process may reduce the dependence upon intensive in process and finished product testing. Our Engineers have been involved in development of various new design concepts for our medical device clients

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Pharmaceutical

Verotech Engineers have been involved in pharmaceutical manufacturing process validation activities with a product lifecycle concept and with existing FDA guidance, including the FDA/International Conference.

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Risk Assessment

The US FDA, European authorities, Health Canada, the Australia Therapeutic Goods Administration and other regulators recognize it as the "de facto" standard for risk management.

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Regulatory affairs

Quality System Implementation

Medical Device

Pharmaceutical

Risk Assessment