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Formal methods have emerged as an alternative approach to ensuring the quality and correctness of the high confidence critical systems, overcoming limitations of the traditional validation techniques such as simulation and testing. This paper presents a methodology for developing critical systems from requirement analysis to automatic code generation with standard safety assessment approach. This methodology combines the refinement approach with various tools including verification tool, model checker tool, real-time animator and finally, produces the source code into many languages using automatic code generation tools. This approach is intended to contribute to further the use of formal techniques for developing critical systems with high integrity and to verify complex properties, which help to discover potential problems. Assessment of the proposed methodology is given through developing a standard case study: the cardiac pacemaker.