Our expert consultants provide an in-depth knowledge of the medical device manufacturing industry to help our clients implement and maintain effective compliance strategies. Our goal is to implement solutions that are compliant to regulations and also help drive business objectives.

Business Management Strategies helps clients from product development, testing to well after the product is being into the manufacturing floor.

Some of the areas where we are successful, include:

Quality Audits and Assessments

Partnering with our clients we help firms identify current and potential gaps in their quality systems.  We perform audits as team members or representing third party auditors, where staff members gain experience and comfort presenting in front of external auditors.

We also support your vendor management program, where our auditors perform the vendor audits in an unbiased and cost-effective manner allowing your staff to focus on internal activities.

Quality Systems Design and Improvement

Our highly experience consultant bring to your table their vast knowledge in quality systems. Having witnessed, reviewed and consulted in many different systems, they help guide and develop a quality system that is suitable for your business needs while achieving a high level of compliance.

Our firm work with clients from startups, needing the full design and implementation of quality systems, associated procedures, processes and forms, to the improvement of fully operational firms that need to improve their effectiveness and reduce costs, all by maintaining compliance and a high level of quality.

We perform quality system assessments, perform a gap analysis using risk management methodologies. We also plan, develop and help execute remediation activities by providing the needed support and guidance throughout the project.

Inspection/Audit Readiness

Our experts help our clients to navigate through inspection activities.  From the pre-inspection readiness verification activities to support inspection activities in the backroom.

BMS can support firms achieve their ISO certification and compliance, from the creation of adequate procedures to coordination with registrars.

Regulatory Bodies Inspection Support, Responses and Remediations

  • Third Party oversight for consent decrees and warning letters remediations
  • Expert consultancy for devising and implementing corrective and preventive actions for the remediation of compliance gaps.
  • Due Diligence audits supporting mergers and acquisitions to assess compliance status and identification of any deficiency and /or gaps that would need to be addressed prior or after merger or acquisition.
  • Inspections support from preparation, duration and after inspections. Supporting our clients devise compliance strategies that would ensure adequate corrective and preventive activities including the execution, monitoring and project’s management.
  • Regulatory and 510k submissions

Quality Engineering

Every project has its unique requirements and specifics.  Our group will work with your firm in order to explore ways to improve the commissioning and qualification processes adapting to client’s changing needs.  Our resources can work as independent contractors or as an extension to the quality and engineering staff.

  • Design Controls
  • Document Controls
  • Manufacturing and production processes improvement
  • Supplier Management
  • Process and Computer Validation
  • Non-Conforming Products investigations
  • Corrective and Preventive Actions
  • Customer Complaints and Reportable Events
  • Internal Audits
  • Products / Technology Transfers