Design, implementation, and improvement of medical device Quality Management Systems compliant with ISO 13485:2016, MDSAP, USA FDA QMSR & 21 CFR Part 11, Health Canada SOR/98-282, Brazil RDC ANVISA 665/2022, Japan MHLW MO 169, Australia TG(MD)R, EU MDR 2017/745 & IVDR 2017/746, IEC 62304:2015. 

Custom QMS implementation tailored to existing processes, operations, and business tools.

Medical device regulatory planning including device classification according to desired marketing jurisdictions (Canada, USA, EU, Australia), identification of relevant safety and performance requirements, and outlining viable regulatory pathways to achieve authorization for both investigational and/or marketing objectives.

Preparation and management of regulatory submissions (e.g. USA FDA 510(k), CE Technical Files, Health Canada License applications) and regulatory interactions (additional information requests, submission meetings).

Design control implementation in accordance with ISO 13485:2016 clause 7.3 Design & Development Controls.

Producing complete Medical Device Files (Design & Development Files, Design History Files, Technical Files, 510(k) eSTAR) covering design inputs, outputs, reviews, verification & validation, design transfer, risk management, and traceability requirements.

Ensuring compliant format and content of nonclinical bench performance protocols and reports.

Assimilating device relevant international standards, regulatory requirements, and regulatory guidance into design and development processes to produce comprehensive Medical Device Files/Design and development files, such as:

• IEC 60601-1 Basic Safety 

• IEC 6060-1-2 EMC Test Planning

• ANSI C63.27 Evaluation of Wireless Coexistence 

• ISO 14971 Safety Risk Management 

• AAMI TIR57 Security Risk management 

• Medical device reprocesssing (cleaning, disinfection, sterilization), per ANSI/AAMI ST98, AAMI TIR12

• Cybersecurity 

• Machine Learning and Al enabled medical devices 

• ISO 10993 Biological evaluation of medical devices

• IEC 62304 Software development files including OTS Software 

• Wireless technology

Certified ISO 13485:2016 Lead Auditor with international experience, trained on MDSAP fundamentals and auditing EU MDR.

Conducting onsite or remote internal audits, and supplier audits. 

Providing an objective and critical assessment of process implementation and recommendations for improvement.

Provide training on ISO 13485:2016 Quality Management Systems including their design and implementation.

Documenting validation of software used in the QMS:

• Specify intended use of software used across the Quality Management System (ISO 13485 clause 4.1.6, 7.5.6, 7.6).

• Develop software validation protocols commensurate with software risk.

• Execute Software Validation.

• Document Software Validation Test Results.

Established network of medical device consultants and service providers to support varying and specialized client needs.