Medical Devices

Qual Conform’s regulatory experts develop winning strategies tailored to your medical device:

– Regulatory landscape assessments and gap analyses

– Device classification and pathway determination (510(k), De Novo, PMA, HDE)

– Pre-submission strategy and FDA meeting preparation

– Design and implementation of pre-clinical and clinical test plans

Qual Conform helps establish robust QMS aligned with FDA requirements:

– 21 CFR Part 820 (Quality System Regulation) compliance

– ISO 13485 certification and maintenance

– Design controls implementation

– Risk management (ISO 14971) integration

– Software validation (IEC 62304) support

Qual Conform streamlines your FDA registration process:

– Establishment registration and device listing guidance

– FDA Establishment Identification (FEI) number acquisition

– U.S. Agent services for foreign manufacturers

– Annual registration renewals and listing updates

Qual Conform maximizes your pre-submission success:

– Q-Submission preparation and strategy

– FDA feedback analysis and response planning

– Meeting preparation and attendance support

Qual Conform guides you through clinical study requirements:

– Investigational Device Exemption (IDE) preparation and submission

– Clinical trial design and protocol development

– IRB submission support and management

Qual Conform’s pharmaceutical regulatory experts develop winning strategies tailored to your drug development program:

– Regulatory landscape assessments and gap analyses

– Drug classification and submission pathway determination (NDA, ANDA, 505(b)(2))

– Pre-IND and pre-NDA meeting strategy and preparation

– Design and implementation of nonclinical and clinical development plans

– Orphan drug designation and fast track designation support

Qual Conform navigates the De Novo pathway for novel devices:

– Risk-benefit analysis

– Classification rationale development

– Comprehensive submission preparation

Qual Conform manages complex PMA submissions for Class III devices:

– Clinical data analysis and presentation

– Manufacturing information compilation

– Labeling and promotional materials review

– FDA advisory committee meeting preparation

Qual Conform ensures robust validation processes:

– Validation master planning

– Process validation

– Equipment and facility validation

– Computer system validation

– Cleaning validation

– Analytical method validation

Qual Conform prepares you for regulatory scrutiny:

– Mock FDA inspections

– Gap analysis audits

– Supplier audits

– FDA inspection readiness and support