We help our clients in providing support solutions in a very broad range of activities, the list below is indicative of the range of skills and experience we can bring to your operations. We can tailor a solution to meet your individual needs in attaining operational excellence.
New Facility Quality Systems Establishment
We have partnered successfully with several client companies to establish quality systems in new facility setups. This includes establishment of the top level Quality Manual and Quality System Procedures, product manufacturing, inspection and testing methods, and certification of quality systems by Notified Bodies. (Refer to our case study section).
FDA Form 483 / Warning Letter Management
We have extensive experience and success in helping companies ensure all responses to inspection citations by FDA clearly provide evidence that the problems were understood, and that lasting and effective solutions have been put in place. We work with local management to correct the problems, and ensure that adequate documentary evidence of correction is included in responses to FDA. This process ensures timely and efficient review by FDA, thereby avoiding additional questions, and the avoidance of subsequent warning letters and import alerts. (Refer to our case study section)
QS Remediation
In addition to FDA Form 483/Warning Letter management we can also provide the necessary expertise and resources to manage and deliver QS Remediation projects following problematic regulatory agency inspections which may have resulted in Import Alerts or Consent Decree events. We have managed such projects successfully either independently or in partnership with other consultancy companies (Refer to our case study section)
Process Validation
In addition to our training and auditing services we can provide independent review and comment on the adequacy of the correct approach to process validation activities. Many companies have taken advantage of this service prior to the execution of process validation work.
Sterilization Validation
We have the expertise to provide objective and critical reviews of terminal and aseptic sterilization processes. We have worked successfully on Ethylene Oxide, Steam, Gamma and EBeam sterilization with various companies. In addition, we have also handled satisfactorily responses to FDA on sterilization validation and control issues arising from difficult inspections.
As an example, for Ethylene Oxide sterilization we can provide:
- Selection of suitable contract sterilization providers.
- Preparation of validation protocols.
- Managing the execution of the protocols.
- Review of the data to insure compliance with AAMI/ISO guidelines.
- Writing of the final report(s).
- Implementation of the Sterilization Release process, including the necessary procedures for cycle review.
- Developing the Procedures for handling Sterilization deviations and product adoptions.
- Establishment of Sterilization Processing Categories, identification of worst-case products for BI placement and suitable design of PCDs.
- Determination of EO residuals.
- Evaluation of Sterile Packaging systems.
(Refer to our case study section).
Software Validation
In addition to our training and auditing services we can bring software expertise to support local management in quality improvement and validation activities. Support can be provided for both medical device software (embedded) and quality system control software.
Design Control
Existing clients have requested us to participate in design reviews and to provide independent review and comment on the adequacy of design verification and validation activities, including risk analysis, prior to the execution of such work and its submission to regulatory agencies.
Product Submissions (510(k), PMA & Technical Files)
We assist in the preparation of product submissions for medical device approval, and preparation of manufacturing facilities for PMA inspection. We have conducted this work for a broad range of devices including sterile disposables and electromechanical devices.
Project Management
We understand that in many situations the range of activities required to deliver on a major project such as a new facility start up requires excellent project management. We have worked successfully with project managers on new facility start-ups and have our own expertise to apply in particularly large projects, to ensure operational excellence is attained.
Mentoring
Our team of highly skilled and experienced professionals can offer clients valuable & impartial advice on a broad range of activities and thus provide a different perspective on how best to drive results and ensure business success, through operational excellence.
Our diverse mix of backgrounds and skill-sets ensures that the best advice & guidance on both general management & more specialised areas can be provided by our mentoring service.
Mentoring has always been a key requirement of any aspiring business. In light of current economic conditions the need for such a business offering has gained in importance and never been as apparent. With many businesses experiencing significant difficulties at present, Medicom is equipped to provide the necessary guidance & support to overcome quality and regulatory challenges.